- In a swift about-face, the Food and Drug Administration has chosen to accept Alkermes plc's New Drug Application for its major depressive disorder drug ALKS-5461.
- Two weeks ago, the agency issued the Irish drugmaker a Refusal to File letter, requesting multiple clinical trials, sending the stock price down.
- ALKS-5461 now has a user fee action date of Jan. 31, 2019. "No additional data or analyses were submitted by Alkermes to FDA," said the company in a statement.
In a surprise move, the FDA has changed its mind about reviewing Alkermes' depression drug — without any new clinical data.
"FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission," the company said in its statement.
The agency's turnaround may be further evidence of a new strategy by FDA Commissioner Scott Gottlieb, who has promised to speed up drug approvals and create more competition within the market.
Gottlieb, appointed by President Trump last year, has been pushing drugs through the regulatory framework at a rapid pace and has frequently spoken publicly about creating more competition, as well as making it easier to bring complex generics and biosimilars forward.
But the move regarding Alkermes is particularly surprising. The ALKS-5461 filing was always considered a long shot, as the NDA was based on very mixed results in Phase 3 and a novel way of pooling the data. ALKS-5461 failed two of its three late-stage trials.
"Given the short time interval, there were no material revisions to the NDA and this is an unexpected and unusual move by the agency. However, we remain cautious on approvability of '5461 given there are still outstanding questions around efficacy, which will undoubtedly be raised during the review process, " wrote Jefferies analyst Biren Amin.
After the flop of the FORWARD-3 and FORWARD-4 studies, Alkermes modified the last late-stage study to include two different dosages of the drug, as well as two stages of the trial that separated out non-responders.
That study, the FORWARD-5 trial, only showed a statistically significant result at the higher dose. At the time, Alkermes planned to pool the data from two of the late-stage studies and submit that to the FDA.
In its Refusal to File letter to the company, the FDA requested multiple new clinical studies, as well as a bioavailability study. Alkermes stock opened up nearly 9% in morning trading on Monday to trade near $46 per share.
This isn't the first reversal of fortune under the new agency administration. Eli Lilly & Co. said in summer 2017 that it will resubmit its rheumatoid arthritis drug baricitinib earlier than expected. In the initial rejection of the drug, the FDA called for more trials, but later reversed course and will allow the application to move forward without more data.