Accelerated Approval: Avastin, Makena Bookend A Watershed Decade For US FDA’s Expedited Pathway
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
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FDA may be evaluating the future of accelerated approval, but data from the Pink Sheet’s Performance Tracker shows growth in the submissions and approvals over the past five years.
ODE I director Ellis Unger chafed at the notion of approving the Duchenne muscular dystrophy drug golodirsen on the same unvalidated surrogate marker, this time in the face of infection and renal toxicity concerns; OND’s Peter Stein granted Sarepta’s appeal while also calling attention to the company’s failure to timely conduct the eteplirsen confirmatory trial.
Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.