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FDA Refuse-To-File Letter For Alkermes Depression Drug Suggests A Lengthy Commercial Delay

 
• By Jessica Merrill

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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Alkermes PLC's hopes to launch a potential blockbuster depression drug later this year have been dashed. The company announced April 2 that it received a refuse-to-file letter from FDA for a new drug application (NDA) for ALKS 5461 for major depressive disorder in patients with an inadequate response to standard antidepressants.

FDA is requesting additional clinical trials before reviewing the application, which suggests a lengthy delay and is particularly problematic for...

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