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FDA accepts Merck’s biologics license application for bezlotoxumab
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The FDA has accepted Merck’s biologics license application for bezlotoxumab, an antitoxin developed for the prevention of recurring Clostridium difficile infection, the company announced today in a press release.
The FDA granted the treatment priority review with a Prescription Drug User Free Act action date of July 23. Bezlotoxumab also is under review by the European Medicines Agency for marketing authorization.
“Recurrence is a major challenge with C. difficile infection, one of the most common health care-associated infections in U.S. hospitals,” Roy Baynes, PhD, senior vice president of clinical development at Merck Research Laboratories, said in the release. “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 approval is based on data from the MODIFY 1 and MODIFY 2 clinical trials that were presented at ICAAC 2015. These multicenter phase 3 trials found that bezlotoxumab significantly decreased C. difficile recurrence among patients when paired with standard antibiotic therapy, especially among those at high risk.
References:
Gerding DN, et al. Phase 3 Double-Blind Study of Bezlotoxumab (BEZ) Alone & with Actoxumab (ACT) for Prevention of Recurrent C. difficile Infection (rCDI) in Patients on Standard of Care (SoC) Antibiotics (MODIFY II). Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 17-21, 2015; San Diego.
Wilcox MH, et al. Phase 3 Double-blind Study of Actoxumab (ACT) & Bezlotoxumab (BEZ) for Prevention of Recurrent C. difficile Infection (rCDI) in Patients on Standard of Care (SoC) Antibiotics (MODIFY I). Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 17-21, 2015; San Diego.
Disclosure: Baynes is an employee of Merck.