Less than a month after the FDA refused to review Alkermes’ new drug application for the company’s depression drug, the agency has changed its mind, according to a statement from the company. After it “clarified certain aspects of the NDA submission”, Alkermes said Monday that the FDA will now accept the application without requiring additional data or analyses.
It’s quite an about-face. According to the company, FDA officials said in a March 30 letter that Alkermes (NASDAQ: ALKS) had provided insufficient evidence of overall effectiveness of the drug, ALKS 5461, and that they required more clinical trials and an additional study of the drug’s bioavailability. Alkermes, which is based in Dublin, Ireland and has U.S. operations in Waltham, MA, said at the time that it would appeal the decision.
The target date for an FDA decision on the Alkermes drug is now Jan. 31, 2019. Investors welcomed the news, sending Alkermes shares up 12 percent to $47.65 Monday morning from Friday.
This development is the latest hurdle cleared by the Alkermes drug, although there’s no guarantee that it will ultimately be approved by the FDA. The oral drug is designed to be taken daily by patients with depression who don’t respond to standard therapies. Phase 3 studies of the drug struggled to meet their main goals, but the company came up with more positive data after tweaking its statistical analysis and Phase 3 endpoints. These tweaks “may have accounted for FDA confusion and will likely remain an issue throughout the review period,” according to a research note from Barclays analysts.