FDA committee vote goes against Alkermes

News Journal

An FDA Advisory Committee has voted that the benefit-risk profile is inadequate to support approval of Alkermes’ new drug application for ALKS 5461, according to a press release from the company.

ALKS 5461 is intended for the adjunctive treatment of Major Depressive Disorder.

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company’s new drug application for ALKS 5461.

In a vote of 21 against and 2 in favor, the committee jointly voted that the benefit-risk profile is not adequate to support approval.

“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,” said Richard Pops, chief executive officer of Alkermes, which has a facility in Wilmington.

“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,” Pops added.

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 new drug application that Alkermes submitted for ALKS 5461.

According to a release from Alkermes, the new drug application submission for ALKS 5461 is 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 major depressive disorder.

The release added that throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of major depressive disorder.

The company stated that ALKS 5461 is a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies.


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