Trulance (Plecanatide) tablets have been approved by US FDA for the treatment of chronic idiopathic constipation (CIC) in adults.
The effectiveness of plecanatide therapy in managing the symptoms of CIC was established in two different clinical studies with total patients of 905 (study 1) and 870 (study 2). The study is a double-blind, placebo-controlled, randomized, multicenter clinical study for a period of 12 weeks.
Plecanatide acts as a guanylate cyclase-C (GC-C) agonist. It triggers GC-C which in turn leads to the increased levels of both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Plecanatide has been shown to elevate the fluid secretion into the gastrointestinal tract and stimulates intestinal transit, thereby the change in the stool consistency occurs.
US FDA approved Parsabiv (etelcalcetide) for treating secondary hyperparathyroidism (HPT) in adults who suffer from chronic kidney disease (CKD) on hemodialysis. However, etelcalcetide is not studied in patients with primary hyperparathyroidism, parathyroid carcinoma or CKD patients who are not on hemodialysis.
Etelcalcetide is a calcimimetic drug that mimics the action of calcium on tissues which acts by binding and activating the calcium-sensing receptor in the parathyroid gland.
The efficacy and safety of etelcalcetide were assessed by two different studies (study 1 - 508 patients and study 2- 515 patients). These studies were randomized, double-blind, and placebo-controlled studies lasted for 26 weeks.
Emflaza (deflazacort) has been approved by US FDA for the treatment of Duchenne muscular dystrophy (DMD) in patients who are 5 years of age and older. DMD is a rare genetic disorder which leads to progressive muscle deterioration and weakness.
The efficacy of deflazacort was evaluated by two multicenter, randomized, double-blind, placebo-controlled studies. Emflaza is a corticosteroid prodrug which is metabolized rapidly to active drug 21-desacetyldeflazacort. It acts by reducing the inflammation and the activity of the immune system. It is available in tablets and oral suspension form.
US FDA approved Siliq (brodalumab) for the treatment of moderate to severe plaque psoriasis in adults for systemic therapy or phototherapy and who have not responded to other systemic therapies.
A total population of 4373 patients were evaluated in a three multicenter, randomized, double-blind, and controlled clinical studies. The subjects are 18 years of age and older with at least a 6-month history of moderate to severe plaque psoriasis.
Brodalumab is a human monoclonal IgG2 antibody that binds to interleukin-17 (IL-17) receptor A which inhibits the IL-17 cytokine-induced responses such as the release of pro-inflammatory cytokines and chemokines.
Xermelo (telotristat ethyl) tablets have been approved by US FDA for treating carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults who show no response to SSA therapy alone.
Telotristat ethyl is a prodrug of telotristat which acts as a tryptophan hydroxylase inhibitor which in turn reduces the production of peripheral serotonin and the frequency of carcinoid diarrhea.
Xermelo clinical studies undergone a double-blind, placebo-controlled, randomized, and multicenter trial for a period of 12 weeks. The subjects involved in the study were adult patients with a well-differentiated metastatic neuroendocrine tumor and carcinoid syndrome diarrhea who had between 4 to 12 daily bowel movements despite the use of SSA therapy at a stable dose for at least 3 months.
US FDA approved Kisqali (ribociclib) tablets in combination with an aromatase inhibitor for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. It is also approved by the European Medicines Agency in August 2017.
Ribociclib is a cyclin-dependent kinase inhibitor which regulates cell cycle progression through the phosphorylation of retinoblastoma protein (pRb).
In clinical studies, the combination of ribociclib and antiestrogen showed a high rate of tumor growth inhibition compared to single drug treatment.
Xadago (Safinamide) has been approved by US FDA as an adjunctive treatment to levodopa and carbidopa in adults patients suffering from Parkinson's disease who experiences off episodes.
It should not be used as a monotherapy in treating Parkinson's disease.
Safinamide is a monoamine oxidase B (MAO-B) inhibitor which acts by blocking the breakdown of dopamine and thereby results in increased dopamine levels with an elevated dopaminergic activity in the brain. It was approved in Europe in February 2015.
Bavencio (Avelumab) has been approved by US FDA for the treatment of metastatic Merkel cell carcinoma (MCC) in adults and pediatric patients who were 12 years of age and older. It is approved under accelerated approval for MCC based on tumor and duration response which will be revised based on clinical benefit.
Avelumab is a monoclonal antibody of isotype IgG1 that binds to programmed death-ligand 1 (PD-L1) which in turn leads to inhibition of CD8+ T cells and blocking an immune reaction. The efficacy and safety of avelumab were evaluated by an open-label, single-arm, multicenter study carried out in patients with confirmed with metastatic MCC whose disease showed progression on or after chemotherapy.
Symproic (naldemedine) has been approved by US FDA for the treatment of opioid-induced constipation in adult patients suffering from chronic non-cancer pain.
Naldemedine for gaining approval undergone phase three clinical studies carried out in adults aged between 18 to 80 years. The studies were 12 weeks, double-blind, randomized, and controlled clinical trials comparing the efficacy of naldemedine with a placebo.
Naldemedine is an opioid antagonist with binding affinities of mu-, delta- and kappa-opioid receptors. It CNS penetration is negligible and acts peripherally as mu-opioid receptor antagonist in the gastrointestinal tract and reduces the constipating effect of opioids.
Zejula (niraparib) capsules have been approved by US FDA as a maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who showed either a complete or partial response to platinum-based chemotherapy.
Niraparib was granted a fast track designation by US FDA. It is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2 which play a vital role in DNA repair. In a study involved 553 patients, progression-free survival (PFS) with BRCA mutation was 21 months in niraparib therapy and 5.5 months in placebo therapy. Patients without such a mutation had a PFS of 9.3 months and 3.9 months under niraparib and placebo respectively.
Dupixent (dupilumab) injection for subcutaneous use has been approved by US FDA for the treatment of moderate to severe atopic dermatitis in adult patients who do not show a response to topical therapies or when topical therapies cannot be advised. Dupilumab can be used either with or without topical corticosteroids.
Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and blocks IL-4R a subunit. As a result, cytokine-induced responses such as the release of proinflammatory cytokines, chemokines, and IgE are inhibited.
Ocrevus (ocrelizumab) injection for intravenous use has been approved by US FDA for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis.
Ocrelizumab is a recombinant humanized monoclonal antibody which binds to CD 20 expressing B cells. It results in antibody-dependent cellular cytolysis and complement-mediated lysis. The efficacy of ocrelizumab was evaluated in two studies of 96 week period, randomized, double-blind, double-dummy, active comparator-controlled clinical trials of identical design in patients with relapsing forms of multiple sclerosis (RMS).
Austedo (deutetrabenazine) tablets have been approved by US FDA for treating chorea associated with Huntington’s disease.
Clinical trials involved 90 patients while 45 received deutetrabenazine and 45 received placebo. The motor signs were improved after 12 weeks of treatment. Patients treated with deutetrabenazine reported an overall improvement in this study.
Deutetrabenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor which results in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
US FDA approved Ingrezza (Valbenazine) capsules for the treatment of tardive dyskinesia in adults.
Valbenazine is a vesicular monoamine transporter 2 (VMAT2) inhibitor that regulates the monoamine uptake to the synaptic vesicles for storage and release.
In vitro studies, valbenazine exhibits greater selectivity to VMAT2 and little to no affinity to VMAT1 or other monoamine receptors. A randomized, double-blind, placebo-controlled clinical study of Ingrezza was conducted in patients who suffer from moderate to severe tardive dyskinesia followed by clinical observation.
Brineura (Cerliponase alfa) injection for intraventricular use has been approved by US FDA to slow the loss of ambulation in symptomatic pediatric patients of 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), which is also named as tripeptidyl peptidase 1 (TPP1) deficiency.
Cerliponase alfa is a purified human enzyme produced by recombinant DNA technology given by intraventricular route which allows significant uptake into the brain. It was also approved by European medicines agency on 30 May 2017.
Alunbrig (brigatinib) tablets have been approved by US FDA for treating patients with anaplastic lymphoma kinase (ALK) - positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or intolerant to crizotinib.
Brigatinib is approved under accelerated approval based on tumor response rate and duration of response but the continued approval is based on clinical benefit. It is a tyrosine kinase inhibitor with in vitro activity against multiple kinases.
The efficacy of Alunbrig was evaluated in a patient population of 222 subjects in a two-arm, open-label, multicenter trial in adult patients who suffer from locally advanced or metastatic ALK-positive NSCLC who are progressed on crizotinib.
Rydapt (midostaurin) capsules have been approved by US FDA for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and systemic mastocytosis in adult patients in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy.
Rydapt is not recommended as a single-agent induction therapy in treating AML. It is a semi-synthetic derivative of staurosporine, an alkaloid from the bacterium Streptomyces staurosporeus.
Tymlos (abaloparatide) injection for subcutaneous use has been approved by US FDA for the treatment of osteoporosis in postmenopausal women who are at a high risk for fracture or patients who failed or showed loss of response to other osteoporosis treatment. Tymlos decreases the risk of both the vertebral as well as nonvertebral fractures in postmenopausal women with osteoporosis.
Abaloparatide is an analog of human parathyroid hormone-related peptide which showed an increase in the bone mineral density and bone mineral content, thereby elevates the bone strength at vertebral and nonvertebral sites. A transdermal patch of abaloparatide is also in the development process.
Cumulative use of Tymlos and parathyroid hormone analogs such as teriparatide for more than 2 years in a patient’s lifetime is not recommended.
Imfinzi (durvalumab) injection for intravenous use has been approved by US FDA for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression either during or following a platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant with platinum-containing treatment.
It has been approved under accelerated approval based on the tumor response rate and the duration of response.Continued approval will be based on clinical benefit.
Durvalumab is a human immunoglobulin G1 kappa monoclonal antibody which blocks the interaction of programmed cell death ligand-1 (PD-L1) with PD-1 and CD80 resulting in increased T-cell activation in vitro and decreased tumor size.
Radicava (edaravone) injection for intravenous use has been approved by US FDA for the treatment of amyotrophic lateral sclerosis (ALS). The efficacy of Radicava for treating ALS was evaluated in a 6 month, randomized, placebo-controlled, double-blind study conducted in Japanese patients with ALS who were living independently. The subjects included in the study were 69 patients in Radicava and 68 in placebo arm respectively.
Edaravone is known to be an anti-oxidant. Formulation of edaravone by mouth named TW001 is under development.
Kevzara (sarilumab) injection for subcutaneous use has been approved by US FDA for treating moderately to severely active rheumatoid arthritis (RA) in adult patients who showed loss of response or intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
The efficacy and safety of Kevzara were evaluated in two studies (study 1 - 1197 patients and study 2 - 546 patients) of randomized, double-blind, placebo-controlled multicenter studies in patients of 18 years of age and older with moderate to severely active RA diagnosed as per the American College of Rheumatology (ACR) criteria.
It has been approved by the European Medicines Agency on 23 June 2017.
Baxdela (delafloxacin) tablets for oral use and intravenous injection has been approved by US FDA for treating adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Delafloxacin is a fluoroquinolone antibacterial which exhibits concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.
A total of 1510 patients with ABSSSI were randomized in a two multicenter, multinational, double-blind, double-dummy, non-inferiority trials. In both these trials, the clinical response after 48 to 72 hours post initiation of treatment showed 20% or even more decrease in the lesion size.
Bevyxxa (betrixaban) capsules for oral use has been approved by US FDA for the prophylaxis of venous thromboembolism (VTE) in adult patients who are hospitalized for an acute medical illness.
The safety and efficacy of Bevyxxa in patients with prosthetic heart valves have not been studied.
Betrixaban is an anticoagulant drug which acts as a direct factor Xa inhibitor which selectively blocks the active site of FXa and does not require a cofactor for activity and has no direct effect on platelet aggregation.
A total of 7513 subjects were evaluated in a randomized, double-blind, multinational study comparing bevyxxa for 35 to 42 days and short duration of 6 to 14 days enoxaparin arm.
Tremfya (guselkumab) injection for subcutaneous use has been approved by US FDA for the treatment of adult patients suffering from moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy. Guselkumab is a human monoclonal antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and thereby inhibits the release of proinflammatory cytokines and chemokines.
The outcomes in the improvement of psoriasis symptoms were evaluated in three multicenter, randomized, double-blind trials enrolled patients 18 years of age and older.
Nerlynx (neratinib) tablets for oral use has been approved by US FDA for the extended adjuvant treatment of early-stage human epidermal growth factor receptor 2 (HER 2)-overexpressed breast cancer in adult patients, to follow adjuvant trastuzumab-based therapy.
It is a kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2 and HER4 reduce the risk of breast cancer returning. The safety and efficacy of Nerlynx were evaluated in a multicenter, randomized, double-blind, placebo-controlled study conducted in 2840 patients with early-stage HER2 positive breast cancer within two years of completing adjuvant trastuzumab therapy.
Vosevi (sofosbuvir, velpatasvir, voxilaprevir) is a fixed-dose combination tablets for oral use which has been approved by US FDA for treating patients with chronic hepatitis C virus (HCV) infection in adult patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) based on genotype infection.
It inhibits the enzyme which is responsible for viral replication. The efficacy of vosevi was evaluated in two phase 3 trials in DAA -experienced patients with respective genotype (HCV) infection without cirrhosis or with compensated cirrhosis. All patients are tested for HBV infection by measuring HBsAg and anti-HBc.
Idhifa (enasidenib) tablets for oral use has been approved by US FDA for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an approved FDA test.
The FDA granted fast track designation and orphan drug status for treating AML. The efficacy of Idhifa was evaluated in an open-label, single-arm, multicenter and two-cohort clinical study involving 199 adult patients with relapsed or refractory AML and IDH2 mutation.
Mavyret (Glecaprevir and Pibrentasvir) is a fixed-dose combination tablet for oral use has been approved by US FDA for treating chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infections in adult patients without cirrhosis or with compensated cirrhosis (Child-Pugh A).
Glecaprevir is an HCV NS3/4A PI and Pibrentasvir is an HCV NS5A inhibitor.In Europe, it was approved in August 2017 for the same indication.
During clinical trials, the fixed-dose combination was found to be effective at clearing all 6 genotypes of HCV from the blood. The trial involved a patient population of 2300 subjects with hepatitis C and showed better response rate during or after the completion of therapy.
Besponsa (inotuzumab ozogamicin) injection for intravenous use has been approved by US FDA for treating adults patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Besponsa contains humanized monoclonal antibody (inotuzumab) against CD22 which is linked to a cytotoxic agent from the group of calicheamicins known as ozogamicin.
The safety and efficacy of Besponsa were evaluated in a randomized, open-label, international, multicenter study in patients with relapsed or refractory ALL. The patient subjects included were patients above 18 years of age and older with Philadelphia chromosome-negative or Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL.
Vabomere (meropenem and vaborbactam) injection for intravenous use has been approved by US FDA for the treatment of patients of 18 years of age and older suffering with complicated urinary tract infections (cUTI) including pyelonephritis caused by susceptible bacteria. Meropenem is a penem antibacterial and vaborbactam is a beta-lactamase inhibitor.
The efficacy of vabomere was evaluated in a patient population of 545 adults in a double-blind, double-dummy, multicenter trial comparing with piperacillin and tazobactam treatment.
Benznidazole tablets for oral use have been approved by US FDA for the treatment of Chagas disease (American trypanosomiasis) in pediatric patients from 2 to 12 years of age which is caused by Trypanosoma cruzi. This indication is approved under accelerated approval based on the number of the treated patients who became IgG antibody negative against the recombinant antigens of T.cruzi.
Continued approval will be based on clinical benefit outcomes.
Benznidazole is a nitroimidazole antimicrobial drug with an antiparasitic property. The safety and efficacy of benznidazole were established in two controlled trials. Trial 1 was carried out in Argentina involved 106 patients while trial 2 was conducted in Brazil with 129 subjects.
Aliqopa (copanlisib) injection for intravenous use has been approved by US FDA for treating relapsed follicular lymphoma (FL) in adults patients who have received at least two prior systemic therapies. It is a selective class I phosphoionositide 3-kinase inhibitor which showed effectiveness in phase I / II clinical trials for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia.
The efficacy of Aliqopa was evaluated in a single-arm, multicenter, phase 2 clinical trial in a total patient population of 142 subjects. Copanlisib induces tumor cell death by apoptosis and inhibition of proliferation of primary malignant B cell lines.
Solosec (secnizadole) oral granules have been approved by US FDA for treating adult women with bacterial vaginosis. Secnidazole is a nitroimidazole anti-infective drug which enters the bacterial cell as an inactive prodrug where the nitro group is reduced by bacterial enzymes which interferes with the bacterial DNA synthesis.
Two randomized placebo-controlled clinical trials with similar designs were conducted to estimate the efficacy of Solosec for treating bacterial vaginosis. Trial 1 included 144 non-pregnant female patients aged between 19 and 54 years and trial 2 included 189 non-pregnant females aged 18 to 54 years.The efficacy was evaluated by the clinical outcome from 21 to 30 days after a single dose of Solosec.
Verzenio (abemaciclib) tablets for oral use has been approved by US FDA for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant with the progression of the disease following endocrine treatment or as a monotherapy in patients with prior chemotherapy in metastatic setting.
Abemaciclib is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6). Two studies were conducted in evaluation of abemaciclib in monotherapy and in combination with fulvestrant therapy. Monarch 1 was a single-arm, open-label, multicenter study conducted in 132 adult females. Monarch 2 was a randomized, placebo-controlled, multicenter study in women population of 669 subjects.
Calquence (acalabrutinib) capsules for oral use has been approved by US FDA for treating mantle cell lymphoma (MCL) who have received at least one prior treatment. This indication approved under accelerated approval and the continued approval will be based on clinical benefit outcomes. It is an anticancer drug and a second generation Bruton’s tyrosine kinase (BTK) inhibitor which is more potent and selective with fewer side effects than ibrutinib.
The efficacy of acalabrutinib was evaluated in an open-label, phase 2 study enrolled a total of 124 patients with MCL who received at least one prior therapy.
Vyzulta (Latanoprostene bunod) has been approved by US FDA, an ophthalmic solution prescribed for reducing the intraocular pressure in patients suffering from open-angle glaucoma or ocular hypertension. Vyzulta was studied in 811 patients in two different controlled clinical trials for a duration of 12 months.
The intraocular pressure (IOP) lowering effect after using latanoprostene bunod in patients with ocular hypertension or elevated IOP was about 7 to 9 mm Hg. The most common adverse reactions observed during the trial are conjunctival hyperemia, eye irritation, eye pain, and instillation site pain in the eye. Nearly 0.6% of patients discontinued the therapy because of some reactions such as blurred vision, punctate keratitis, and foreign body sensation.
Prevymis (Letermovir) tablets for oral use and injection for intravenous use has been approved by US FDA for prophylaxis of cytomegalovirus (CMV) infection and the disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HCST). Prevymis is not recommended for patients taking pimozide or ergot alkaloids.
About 565 patients were evaluated in a multicenter, double-blind, placebo-controlled Phase 3 trial either with prevymis of 480mg once daily adjusted to 240mg when taken with cyclosporine or placebo. The subjects were assessed for a follow-up through week 48 post-transplant. The Kaplan Meier event rate for all-cause mortality in the study of letermovir with placebo group was found to be 12% & 17% at week 24 and 24% & 28% at week 48 post-transplant.
Fasenra (Benralizumab) injection for subcutaneous use has been approved by US FDA as an add-on maintenance treatment of severe asthma patients aged 12 years and above, and with an eosinophilic phenotype.
Patients of about 609 with 18 years of age and above were evaluated in phase 2, randomized, double-blind, placebo-controlled, 52 week dosing trial by administering 2mg, 20mg or 100 mg of benralizumab subcutaneous injection or placebo. Results from trial supported the evaluation of benralizumab 30mg and not in 2mg, 20mg or 100mg doses. Hence the dose of recommended 30 mg only should be used.
Fasenra is not recommended to treat acute bronchospasm or other eosinophilic conditions.
Mepsevii (Vestronidase alfa-vjbk) is a recombinant human lysosomal beta-glucuronidase as an injection for intravenous use has been approved by US FDA for treating mucopolysaccharidosis VII (MPS VII, Sly syndrome) in adult and pediatric patients.
During the clinical trial, the most common adverse reactions reported with mepsevii treatment was diarrhea, rashes, infusion site swelling or extravasation, peripheral swelling or pruritus. One patient experienced a febrile convulsion during the mepsevii treatment. The European Medicines Agency (EMA) is currently reviewing the marketing authorization application for vestronidase alfa in Europe.
Hemlibra (Emicizumab-kxwh) injection for subcutaneous use has been approved by US FDA for routine prophylaxis either in preventing or reducing the episodes of bleeding frequency in adult and pediatric patients with hemophilia A with factor VIII inhibitors.
The efficacy of hemlibra was evaluated in two clinical trials involving an adult and adolescent study (HAVEN 1) and a pediatric study (HAVEN 2). Cases of thrombotic microangiopathy and thrombotic events were also reported during the study and a close monitoring is required if a prothrombin complex concentrate was administered.
Ozempic (Semaglutide) injection for subcutaneous use has been approved by US FDA for treating adults with Type 2 diabetes mellitus. Semaglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist used as an adjunct to diet and exercise to improve glycemic control. It is administered once a week.
Semaglutide found to lower the glycosylated hemoglobin in a clinical trial carried out in 8000 adults with type 2 diabetes. However, it is not recommended to use in patients with pancreatitis, diabetic ketoacidosis or type 1 diabetes. The drug has a risk of causing thyroid C- cell tumors and diabetic retinopathy complications. The common side effects are nausea, vomiting, abdominal pain, diarrhea or constipation.
Xepi (Ozenoxacin) is a quinolone antibiotic cream for topical use has been approved by US FDA for the treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in adults patients and in children from 2 months of age and above.
The safety and efficacy of ozenoxacin have been evaluated in a two multicenter, double-blind, randomized, placebo-controlled trial involving 723 patients. However, patients with skin trauma, secondary infection, and pre-existing eczematous dermatitis are excluded from the clinical study. The prolonged use of ozenoxacin leads to overgrowth of nonsusceptible bacteria and fungi. Rosacea and seborrheic dermatitis are reported very rarely in the treated groups.
Rhopressa (Netarsudil) is a 0.02% ophthalmic solution, a Rho kinase inhibitor approved by US FDA for the treatment of raised intraocular pressure in patients suffering from ocular hypertension or open-angle glaucoma.
Netarsudil was evaluated in a three controlled and randomized clinical trials which were referred to as study 301, 302, and 304 in patients with open-angle glaucoma. Patients with a baseline intraocular pressure (IOP) lower than 27 mm of Hg are included in study 301 and 302 whereas in study 304 patients with baseline IOP lower than 30 mm of Hg were enrolled. The study duration of 301, 302, and 304 lasted for about 3 months, 12 months, and 6 months respectively.
Steglatro (Ertugliflozin) tablets have been approved by US FDA as an adjunct to diet and exercise in adult patients with type 2 diabetes mellitus to improve glycemic control. It is a sodium-glucose co-transporter-2 (SGLT2) inhibitor which is not recommended for patients with type 1 diabetes or patients with diabetic ketoacidosis.
The safety and efficacy of ertugliflozin have been evaluated in 7 multicenter, randomized, placebo or active comparator-controlled, double-blind clinical studies. These studies enrolled nearly 4863 patients with type 2 diabetes mellitus. Ertugliflozin was studied both as a monotherapy and in combination with metformin and sitagliptin which showed a reduction in HbA1c compared with placebo.
Macrilen ( Macimorelin acetate) oral solution is a growth hormone (GH) secretagogue receptor agonist approved by FDA for the diagnosis of adult growth hormone deficiency. However, the macimorelin oral solution is not recommended in people with a body mass index >40 kg/m2.
The efficacy of macimorelin was evaluated in a randomized, single-dose, open-label, cross-over study with the aim of comparing the result levels between the macimorelin test and the insulin tolerance tests in patients with growth hormone deficiency and healthy subjects. The dose is to be administered as a reconstitution solution in patients who fasted for at least 8 hours.
Giapreza (Angiotensin II) is a vasoconstrictor injection for intravenous infusion use approved by FDA to raise the blood pressure in adult patients with septic or a distributive shock. The ATHOS-3 (Angiotensin II for treating high output shock) trial is a double-blind, randomized, and placebo-controlled clinical study which involved 321 adult patients with septic or distributive shock who remained hypotensive despite fluid and vasopressor therapy.
The trial which was evaluated for the safety of angiotensin II showed a higher incidence of various thromboembolic events with arterial and venous thrombotic events with a major imbalance in deep vein thromboses. Concurrent venous thromboembolism prophylaxis has to be considered with the angiotensin II therapy.
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