C.Diff Unmet Need Overcomes Bezlotoxumab Panel's Efficacy Concerns
This article was originally published in The Pink Sheet Daily
Executive Summary
Advisory committee votes 10-5 for approval of the monoclonal antibody for prevention of C. difficile recurrence; drug shows 10% absolute reduction in recurrence vs. placebo.
You may also be interested in...
Merck’s C. Diff Drug Zinplava Clears FDA With Heart Failure Warning
Following panel recommendation, label includes warning of use of bezlotoxumab in patients with history of congestive heart failure; postmarketing commitments include studies on microbial retention and endotoxin recovery.
Merck & Co Expands C Diff Franchise With US Zinplava Approval
Merck & Co is planning a first-quarter 2017 launch of Zinplava, its novel therapy for use in Clostridium difficile infection, following a US FDA approval, strengthening the company’s leading position in an infectious disease with great unmet need.
Keeping Track: Approval Elusive For Biosimilar Neulasta; Valeant Gets A Nod And A No From FDA; Submissions From Amgen, Puma, Bristol
The latest drug development news and highlights from our FDA Performance Tracker