Alkermes secures US watchdog U-turn on depression drug
Food and Drug Administration accepts filing from Irish pharma group fortnight after refusal
Alkermes reckons more than eight million people in the US alone suffer from a major depressive disorder. File photograph: Getty Images
In an unexpected U-turn, the US drug regulator said it has accepted ALKS-5461 for review. It has set a target date of end-January 2019 for a decision on the therapy.
At the end of March, the FDA issued a formal letter saying it could not even consider the drug’s potential because of insufficient evidence of its efficacy in clinical trials. It said, at that time, that Alkermes would need to conduct more tightly controlled trials before resubmitting the drug.
Alkermes responded angrily to the setback, said it disagreed strongly with the regulator and planned to appeal. “To say we were surprised would be an understatement,” said Alkermes chief executive Richard Pops on a conference call with analysts.
At the time, analysts suggested a chance for a reprieve were slim. Analyst Cory Kasimov at J P Morgan Chase removed the drug entirely from his pricing model for the company’s shares on the back of the refusal which he described as “markedly more negative than usual” for refusal to file letters.
On Monday the company said “FDA’s acceptance of the ALKS 5461 NDA [new drug application] and rescission of the Refusal to File letter follows productive interactions with the agency in which Alkermes clarified certain aspects of the submission”.
The company said no additional data or analyses were submitted to support the application.
Shares in the group were 8.5 per cent higher in US trade late morning. The FDA refusal at the start of the month had knocked more than 20 per cent off the company’s market value.
ALKS-5461 is a daily oral drug for treatment of major depressive disorder in patients who have haven’t responded as well as expected to frontline antidepressant drugs.
Alkermes reckons more than eight million people in the US alone suffer from a major depressive disorder, which is defined as a condition where patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period alongside impaired social, occupational, educational or other important functioning.
The company’s chief medical officer, Dr Craig Hopkinson, said the FDA filing was “a positive step forward for patients suffering from major depressive disorder, a serious disease where inadequate response to existing antidepressants remains a well-known and significant treatment limitation, and where there have been no new pharmacological treatment approaches in 30 years”.
Alkermes became an Irish domiciled company with its takeover of Elan Drug Technologies in Athlone in 2011.