Alkermes Advisory Committee Hears More About Refuse-To-File Letter Thanks To Industry Rep
US FDA’s decision to issue refuse-to-file action for Alkermes’ buprenorphine/samidorphan combo for major depressive disorder was one of the review issues brought to light by an unusually active advisory committee industry representative.
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Nearly every panelist cited lack of substantial evidence of efficacy in voting against approval of ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan.
US FDA accepts Alkermes' NDA for depression drug after issuing refuse-to-file letter just two weeks ago; unusual move falls outside agency's guidance on RTFs because no changes were made to submission and it wasn't filed over protest.
Accelerated Approvals Convert Much Faster If Confirmatory Trial Already Underway, FDA Cancer Data Shows
Oncology Center of Excellence’s ‘Project Confirm’ finds that if a confirmatory trial is ongoing at the time of accelerated approval, conversion to regular approval takes an average of three years versus 4.9 years if the trial starts after AA.