FDA Panels Vote Against Recommending MDD Drug, ALKS 5461

The committee jointly voted 21-2 against recommending approval, noting that the benefit-risk profile was not adequate to support approval.

Officials with the FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee have recommended against approving ALKS 5461 (Alkermes), an investigational major depressive disorder medication (MDD).

The committee jointly voted 21-2 against recommending approval, noting that the benefit-risk profile was not adequate to support approval.

The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD.

"We were disappointed and surprised by the FDA's characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the Advisory Committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants," Richard Pops, Chief Executive Officer of Alkermes said in a statement released after the committee meetings. "We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission."

Advisory committees provide the FDA with independent expert advice and recommendations on the safety and efficacy of potential new medicines. The advisory committee's recommendation, while not binding, will be considered by the FDA in its review of the NDA that Alkermes has submitted for ALKS 5461. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 5461 NDA of Jan. 31, 2019.