Merck is nearing FDA approval for its Clostridium difficile-fighting antibody, picking up the agency’s priority review designation with the promise of a shortened vetting process.
The FDA accepted Merck’s application for bezlotoxumab and promised to hand down a final decision by July 23, shortening the standard 10-month review to 6 months.
The treatment, licensed from Medarex in 2009, is an antibody designed to block C. difficile toxin B, which damages the gut wall and leads to inflammation that trigger abdominal pain and diarrhea. In Phase III, adding bezlotoxumab to standard of care significantly reduced C. difficile recurrence in high-risk patients after 12 weeks, Merck disclosed in September.
Bezlotoxumab is among the most advanced assets in Merck’s infectious disease pipeline, bolstered by the company’s $9.5 billion buyout of antibiotics specialist Cubist Pharmaceuticals last year. Merck is also at work on therapies for pneumonia, bacterial infection and HIV as it awaits approval for a combination treatment targeting hepatitis C.
FULL STATEMENT FROM MERCK:
Merck known as MSD outside the United States and Canada January 28, 2016 (today) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.
The FDA granted Priority Review for bezlotoxumab, with a Prescription Drug User Fee Act (PDUFA) action date of July 23, 2016.
The company also has filed a marketing authorization application for bezlotoxumab with the European Medicines Agency (EMA) that is currently under review.
“Recurrence is a major challenge with C. difficile infection, one of the most common healthcare-associated infections in U.S. hospitals,” said Dr. Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “Currently, there are no therapies approved for the prevention of C. difficile infection recurrence. As part of Merck’s commitment to the fight against infectious diseases, we look forward to continuing to work with the FDA and EMA to bring forward this novel medicine for appropriate patients.”
The application for bezlotoxumab is based in part on data from the pivota lMODIFY I and MODIFY II clinical trials. Data from these trials were previously presented at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) 2015 joint meeting.
Bezlotoxumab is an investigational antitoxin given in conjunction with standard of care antibiotics that are used in the treatment of C. difficile infection. It is not an antibiotic. Bezlotoxumab is designed to neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to C. difficile-associated diarrhea.
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Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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