Merck ($MRK) 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.
Merck abandoned a second C. difficile therapy, actoxumab, last year after it failed to substantially improve symptoms when paired with bezlotoxumab in a late-stage trial.
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