Breakthrough Designation Rescissions: Who Might US FDA Drop Next?
Our chart details the pipeline candidates who might lose the coveted status as treatment paradigms change and trial results come in.
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Investor unrest expected as Allergan’s NMDA receptor modulator rapastinel fails in Phase III depression program, coming shortly after J&J’s approval in the class with Spravato.
Synthetic Biologics emerged from meetings with US FDA without its breakthrough designation, but with hope that agency will allow decoupling of safety and efficacy endpoints in planned Phase III trial for prevention of C. difficile infection.
Recent approvals of hepatitis C treatments Sovaldi, Harvoni and Viekira Pak lead agency to reconsider ‘breakthrough’-worthiness of Bristol’s daclatasvir and Merck’s doublet therapy. FDA’s willingness to rescind shows the risk sponsors face in trying to retain the designation as other competitors reach market.