Keeping Track: Regeneron Ebola Antibody Cocktail Inmazeb Approved; Avenue Feels Pain From CRL; Scynexis Submits Oral Antifungal
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease
News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols
Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.
Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted
Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.