Bye, Bye ‘Breakthrough’: Bristol, Merck HCV Drugs Face Loss Of Special Designation
Executive Summary
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.
You may also be interested in...
Breakthrough Therapies: Failed Study Won’t Automatically Lead To Rescinded Designation
The decision to maintain or revoke breakthrough therapy status when trial results do not appear to support the original designation will depend on the facts specific to a development program, the US FDA says in new draft guidance. Since 2012, the agency has granted 475 breakthrough therapy designation requests and rescinded 35 designations.
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.
No Safety Shortcuts Under Breakthrough Designation, Synthetic Biologics Finds
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.