- The Food and Drug Administration has declined to approve an experimental depression drug from Alkermes, the company revealed Friday.
- The biotech received a Complete Response Letter for its antidepressant ALKS-5461, designed for the adjunctive treatment of major depressive disorder. Alkermes said the FDA requested more clinical data to demonstrate the drug's effectiveness, and indicated it planned to meet with the agency to discuss whether "there is a viable path forward" for the treatment.
- Alkermes' stock opened down about 3% Monday, as the FDA's decision was largely anticipated after an advisory committee voted 21-2 against recommending approval last November. Over the past 12 months, company shares have dropped by more than 40%.
Alkermes' case for approval of ALKS-5461 was shaky even before the FDA's advisory committee found the drug's clinical evidence wanting.
In studies called FORWARD-3 and FORWARD-4, ALKS-5461 failed to hit its primary goals. In its submission to the FDA in January 2018, Alkermes pointed to favorable evidence of efficacy for one dose in FORWARD-4, as well as positive results from the Phase 3 FORWARD-5 study.
The FDA identified a number of areas in which it took issue with Alkermes' approach, including a method of constructing clinical trials called sequential parallel comparative design. The technique re-randomizes placebo non-responders to receive either the trial drug or be given placebo again.
The agency had also advised against modifications Alkermes made to measure success in FORWARD-5, documents prepared by FDA staff ahead of the November advisory committee meeting showed.
In making its case, Alkermes argued that the FDA's more flexible approach in oncology should be adopted in other therapeutic areas as well — depression being a field with fewer innovations in study methodologies.
With a path forward looking uncertain for ALKS5-461, Alkermes has more recently focused on its experimental schizophrenia drug ALKS-3831, which succeeded in a second Phase 3 study late last year.