April 2, 2018 / 11:17 AM / a year ago

FDA rejects application to review Alkermes' depression treatment

April 2 (Reuters) - Alkermes Plc said on Monday the U.S. Food and Drug Administration rejected the application seeking approval for its experimental depression drug, citing insufficient evidence of effectiveness.

The company said it strongly disagreed with the FDA and planned to appeal the regulator's decision after the regulator sent a "Refusal to File" letter to the company.

The drug, ALKS 5461, is being tested as adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. (Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)

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