Avastin Vs. Makena: A Comparative Timeline Of The Two Accelerated Approval Withdrawal Fights
The effort to remove Makena from the market has already lasted longer than the Avastin process from initial advisory committee vote favoring withdrawal until the final order, and the Makena appeal hearing hasn’t even been scheduled yet.
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US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
The Makena Deciders: FDA Commissioner Califf, Chief Scientist Bumpus To Jointly Make Final Call On Drug’s Fate
The two senior agency officials will render the decision together as co-signatories on whether Makena loses its accelerated approval or is allowed to stay on the market; that decision will not come before mid-January, and is likely to be weeks or months later, based on a timeline set out by hearing officer Celia Witten.
Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing
The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.