Alkermes' Depression Drug Likely Needs Another Trial After Crushing US Advisory Cmte. Vote
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.
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The latest drug development news and highlights from our US FDA Performance Tracker.
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.
Alkermes showed that combo pill ALKS 3831 offers a better weight gain profile compared to olanzapine in schizophrenia patients, but analysts differed on whether the benefit would be great enough to drive demand against entrenched generics.