Alkermes ENLIGHTEN Hints At Efficacy Benefit But Weight Profile Still In Balance
The first Phase III trial results for Alkermes' combination product for schizophrenia ALKS 3831 show hints of added benefit over olanzapine alone but no benefit yet on weight gain, the product's raison d'être. Analysts are hoping upcoming longer-term data will produce the goods.
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Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa
The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
Is Alkermes’ Schizophrenia Data Enough To Drive Demand?
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.
COMMENT: Alkermes Needs New Strategy In Wake Of Trial Failures
Following the failure of two pivotal studies, Alkermes is unlikely to keep ALKS 5461 alive and must instead redefine its strategy, says Datamonitor Healthcare lead analyst Daniel Chancellor.