C.Diff Unmet Need Overcomes Bezlotoxumab Panel's Efficacy Concerns
This article was originally published in The Pink Sheet Daily
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.
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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 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
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