Vabomere Drug Set to Hit the Market as New Medicine for Infections

Vabomere - a combination of an antibiotic and new beta-lactamase inhibitor can help address the issue of bacterial resistance.

European Medicines Agency (EMA) has recommended granting a marketing authorisation for Vabomere as a new treatment option against the following infections in adults:

Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them;
Complicated intra-abdominal infection;
Hospital-acquired pneumonia, including ventilator associated pneumonia;
Bacteria in the blood associated with any of the infections listed above;
Infections due to aerobic Gram-negative organisms in adults with limited treatment options.

FDA Issues Life-Threatening Warning Against Eating Foods With Liquid Nitrogen
FDA advises against eating foods prepared with liquid nitrogen as it may lead to life-threatening injuries.

‘By inhibiting the action of beta-lactamases, vaborbactam can protect meropenem from being inactivated and restores its activity against many, but not all, carbapenem-resistant pathogens.’

Tweet it Now

The lack of availability of medicines to treat patients with infections caused by resistant bacteria has become a major problem in recent years. It is estimated that at least 25,000 patients in the European Union (EU) die each year from infections due to bacteria that are resistant to many medicines.

Vabomere is a fixed combination of vaborbactam, a new beta-lactamase inhibitor and meropenem, a broad-spectrum antibiotic belonging to the class of carbapenems that is already approved for use in the EU. It is a powder for concentrate for solution for infusion (drip into a vein).

Resistance to carbapenems has been increasing lately, in particular in Gram-negative bacteria, and is of major concern. Beta-lactamases are enzymes involved in bacterial resistance to these antibiotics. By inhibiting the action of beta-lactamases, vaborbactam protects meropenem from being inactivated and restores its activity against many, but not all, carbapenem-resistant pathogens.

Vaginal Rejuvenating Therapies Up Risk for Women: Warns FDA
Women who opt for Vaginal rejuvenation procedures to improve vaginal tone or pelvic function are at high risk as these procedures are extremely unsafe, warns the US Food and Drug Administration (FDA).

In the clinical development program, the exposure to vaborbactam at the recommended dose was shown to be sufficient to protect the activity of meropenem against carbapenem-resistant Enterobacteriaceae. The CHMP also agreed that the studies did not indicate any major concerns regarding the safety profile of meropenem-vaborbactam.

EMA contributes to the European and global effort to tackle antimicrobial resistance. A major area of activity is to create an environment that stimulates and facilitates the development of new antimicrobials. The Agency's activities also include the monitoring and analysis of data on antimicrobials to guide policy and research, as well as the promotion of their responsible use.

FDA Warns On Fatal Risk of Misdosing Ocaliva
The US Food and Drug Administration warned clinicians that excessive doses of Ocaliva for patients with liver disease can result in serious injury or death.

The opinion adopted by the CHMP is an intermediary step on Vabomere's path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once the marketing authorization has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.

Source-Medindia

FDA Approves Immunotherapy Drug Combination of Ipilimumab, Nivolumab to Treat Kidney Cancer
A combination of two immunotherapy drugs, ipilimumab and nivolumab has been approved by FDA to improve treatment of metastatic kidney cancer. Clinical trials showed higher response rate and improved survival in kidney cancer patients.