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FDA Committees' Unfavorable Ruling Depresses Alkermes Shares

FDA Committees' Unfavorable Ruling Depresses Alkermes Shares

Alkermes Plc (NASDAQ: ALKS) shares were trading down Friday as the Street weighed reports of regulatory setbacks for the biopharma. 

What Happened

The Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly recommended not to approve Alkermes’ ALKS 5461.

Their review of the candidate found two of the studies to be statistically insignificant — a finding at odds with the conclusions drawn by Alkermes. Ultimately, they ruled the risk-benefit profile of the treatment for major depressive disorder unfavorable.

Why It’s Important

The committees’ recommendation does not guarantee rejection, according to STAT News. Alkermes remains hopeful that the FDA at large will reach a more favorable conclusion.

"We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission,” Alkermes CEO Richard Pops said in a press release.

The company reiterated in its announcement that ALKS 5461’s clinical program revealed consistent antidepressant activity, as well as safety and tolerability.

What’s Next

The FDA will announce its ruling by the drug’s Prescription Drug User Fee Act date on Jan. 31, 2019.

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Posted-In: antidepressants Stat NewsBiotech News FDA Media General Best of Benzinga


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