FDA Refuse-To-File Letter For Alkermes Depression Drug Suggests A Lengthy Commercial Delay
CEO Richard Pops called FDA's letter for ALKS 5461 "surprising and troubling." Alkermes had been ramping up to launch the depression drug later this year, though some investors had remained skeptical.
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Keeping Track Of Non-Oncology Review and Approval News: Erectile Dysfunction, Parkinson's, Cholesterol
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Immuno-oncology R&D based around an interleukin-2 agonist in early clinical studies has attracted attention to Alkermes, but the CNS disorders specialty company is also concentrating on a new mechanism-of-action antidepressant that is nearing the market, and a new antipsychotic.
Celgene said the US FDA issued a refuse-to-file letter for ozanimod in multiple sclerosis because "the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a review." It's yet another big blow for a company whose value has been falling since October.