Alkermes likely headed for approval after adcomm waves through schizophrenia and bipolar program
Alkermes may finally be on the verge of an approval in the psychiatric field a little less than two years after the FDA rejected its drug for depression.
In a joint adcomm Friday, PDAC and DSRMAC met to discuss whether the opioid antagonist portion of Alkermes’ ALKS-3831 helped prevent weight gain in adults with schizophrenia and bipolar I disorder. Across three votes, the adcomm indicated broad support for the experimental drug, including a 16-1 tally agreeing that the candidate meaningfully mitigates weight-gain risk.
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