About Careers Internship MedBlog Contact us
Medindia LOGIN REGISTER
FDA Approves Brodalumab Drug for Psoriasis Treatment
Advertisement

FDA Approves Brodalumab Drug for Psoriasis Treatment

Font : A-A+

Highlights
  • Psoriasis is a skin condition which causes redness and scaly patches on the skin
  • The Food and Drug Administration (FDA) approved brodalumab drug for psoriasis treatment
  • Brodalumab drug found to be effective in the treatment of moderate-to-severe plaque psoriasis. The drug is available only through Risk Evaluation Mitigation Program (REMS)

The United States Food and Drug Administration (USFDA) has approved Brodalumab drug for the treatment of moderate-to-severe plaque psoriasis.

Psoriasis is an autoimmune disease which causes redness and scaly patches on the skin. Plaque psoriasis is the most common type of psoriasis and is responsible for 80% of the total cases.

Advertisement


Brodalumab drug (Siliq) is administered as an injection. The drug is intended for systemic therapy using substances which can travel through the bloodstream after taking the injection, or ultraviolet therapy and have failed to respond or stopped responding to the other therapies.

Julie Beltz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said, "Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients, and today's approval provides patients with another treatment option for their psoriasis."
Advertisement

"Patients and their health care providers should discuss the benefits and risks of brodalumab drug before considering treatment."

Brodalumab - Mechanism of Action
The active ingredient of the drug mainly acts by binding to a protein which causes inflammation and inhibits the inflammatory response which plays a role in plaque psoriasis.

Clinical Trial
The efficacy and safety of brodalumab drug were established in three randomized, placebo-controlled clinical trial on 4,373 participants who have moderate-severe plaque psoriasis who were eligible for systemic therapy or phototherapy.

The results of the clinical trial conducted on patients who took brodalumab drug were compared to the patients who took placebo. More number of patients who took brodalumab drug were found to have a clear or almost clear skin when compared to the placebo. This was assessed by scoring the extent, nature and severity of the skin changes.

Risk of Suicidal Ideation and Behavior
The patients who were treated with brodalumab drug in clinical trials had a risk of suicidal ideation and behavior. These users with a history of suicidality or depression may further have an increased risk of suicidal ideation or behavior.

Due to the observed risk, the labeling for brodalumab drug includes a boxed warning and the drug can be available only through the Risk Evaluation and Mitigation Strategy (REMS)

The requirements of the Brodalumab Risk Evaluation and Mitigation Strategy (REMS) Program include

  • Physicians who prescribe the drug must be certified with the program and must counsel patients about the risk. The patients have to be referred to a mental health professional if there are any new or worsening symptoms of depression or suicidality.
  • A patient-prescriber agreement form has to be signed by the patient and they must be aware of the need for medical attention as they can experience new or worsening symptoms or changes in the mood.
  • The pharmacies must also be certified and must dispense the drug to only authorized patients who receive brodalumab drug.
Common Side Effects of Brodalumab Drug
  • Joint pain
  • Headache
  • Fatigue
  • Diarrhea
  • Throat pain
  • Nausea
  • Muscle Pain
  • Influenza
  • Low white blood cell count
  • Fungal infections
The drug is approved along with a medication guide which informs the patient about the risk of suicidal ideation and behavior. The drug may also affect the immune system and may have an increased risk of acquiring infection.

Note: The drug must not be injected to patients who have active tuberculosis infections.

They must avoid immunizations with live vaccines when treated with brodalumab drug

Facts on Psoriasis
  • Psoriasis occurs commonly in patients who are with a family history of the disease.
  • People between the age of 15 and 35 years are more prone to psoriasis.
  • The common form of psoriasis is plaque psoriasis where the patient skin is accompanied with redness and flaky silver-white scales.
  • Around 11% of people diagnosed with psoriasis are also being diagnosed with psoriatic arthritis.
  • It is estimated that around 20,000 children below 10 years of age are diagnosed with psoriasis every year.
References
  1. About Psoriasis - (https://www.psoriasis.org/about-psoriasis)
  2. FDA approves new psoriasis drug - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm)


Source: Medindia

Citations   close

Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
What's New on Medindia
Alarming Cesarean Section Trends in India - Convenience or Compulsion of Corporate Healthcare
Quiz on Low-Calorie Diet for Diabetes
World Heart Day in 2022- Use Heart for Every Heart
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Drug Toxicity Signature Drug Toxicity Psoriasis Drugs Banned in India Dry Skin Symptom Evaluation Foods that are Bad for your Skin Itchy Scalp Diet for Psoriasis Scalp Psoriasis Psoriasis Cure with Homeopathy: Fact or Fiction 

Most Popular on Medindia

Accident and Trauma Care Daily Calorie Requirements Find a Hospital How to Reduce School Bag Weight - Simple Tips Drug Interaction Checker Blood Pressure Calculator Post-Nasal Drip Iron Intake Calculator Blood - Sugar Chart Loram (2 mg) (Lorazepam)
This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use
×

FDA Approves Brodalumab Drug for Psoriasis Treatment Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests