In an about-face, the FDA reportedly agreed to review a new drug application for Alkermes‘ (NSDQ:ALKS) depression drug just weeks after the agency said it would only do so if the company conducted additional trials.
Alkermes’ once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with major depressive disorder for whom standard antidepressant therapies have not worked.
The company’s move to file an application in the first place for ALKS 5461 was seen as a gamble – the drug failed two Phase III trials and managed to succeed only after the company redesigned a third late-stage study.
Alkermes said the FDA agreed to accept its NDA after the company “clarified certain aspects” of the application. The company did not submit an additional data or analyses.
“FDA’s filing of the ALKS 5461 application is 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,” Dr. Craig Hopkinson, CMO & SVP of medicines development and medical affairs at Alkermes, said in prepared remarks.
“We will continue to engage with the FDA throughout the review process, as we work to bring this important medicine to patients,” he added.
ALKS shares were trading at $44.07 apiece in mid-afternoon activity today, up 3.7%.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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