FDA Approves Eptinezumab, Ofatumumab Accepted for Supplemental Biologics License Application, Deutetrabenazine Fails in Tourette Syndrome

This week Neurology News Network covered the FDA approval of eptinezumab for the prevention of migraine in adults, as well as a new supplemental biologics license application for a multiple sclerosis treatment. Additionally, we discuss the failed trial of deutrabenazine for the treatment of tics in pediatric patients.

Marco: Welcome to Neurology News Network. I’m Marco Meglio. Let’s get into the news from this week.

The FDA has approved eptinezumab for the prevention of migraine in adults. The drug, which is the first-ever intravenous migraine prophylactic, will become available for prescription in April 2020, with a recommended dose of 100 mg quarterly. The agency’s decision was supported by data from a set of 2 phase 3 clinical trials—PROMISE-1 and PROMISE-2, in episodic and chronic migraine, respectively. The findings of which suggested that the humanized monoclonal antibody was beneficial over placebo as early as 1-day post-infusion. The CGRP drug joins a growing field of migraine preventives in that class, including erenumab, galcanezumab, and fremanezumab, all of which are delivered via injection.

The FDA has accepted the supplemental biologics license application for ofatumumab, a novel B cell-targeting therapy indicated for the treatment of relapsing forms of multiple sclerosis. The drug, a fully human antibody targeting CD20-positive B cells, was also simultaneously accepted for review by the European Medicines Agency. The therapy, which is administered monthly via subcutaneous injection, demonstrated significant efficacy over teriflunomide in the head to head phase 3 ASCLEPIOS I and II trials, which included 1882 patients with MS age 18 to 55. The FDA has assigned a PDUFA date of June 2020 for ofatumumab.

Teva Pharmaceuticals has announced that the 2 trials designed to assess its VMAT2 inhibitor deutetrabenazine in the treatment of tics in pediatric patients with Tourette syndrome failed to meet their primary end points. The agent, which has also been assessed in tardive dyskinesia, failed to reduce motor and phonic tics compared to patients administered placebo, as assessed by total tic score on the Yale Global Tic Severity Scale. Deutetrabenazine was originally approved by the FDA in April 2017 as Austedo for the treatment of chorea associated with Huntington disease and for the aforementioned tardive dyskinesia treatment in adults in August 2017.

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