FDA Requests Additional Information, Extends Target Date for Application of MS Treatment

November 18, 2022

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The FDA has extended the target date for prescription drug users to Dec. 28, regarding TG Therapeutics’ application for a biologics license for ublituximab for patients with relapsing-remitting multiple sclerosis.

According to a release issued by TG, ublituximab is an investigational glycotechnology monoclonal antibody that targets a specific site on CD20-expressing B cells. The FDA needed additional time to review the submissions provided in response to the information request, which included the integration and summary of certain clinical information previously provided to the FDA by TG.

The Food and Drug Administration has extended the Prescription Drug Fee Act for ublituximab, an investigational glycotechnology monoclonal antibody for the treatment of relapsing-remitting multiple sclerosis. Source: Adobe Stock

“While we are disappointed with our extension [Prescription Drug User Fee Act (PDUFA)] target date for ublituximab, a delay of this length is not unprecedented, as both CD20 agents currently on the market in MS experience a similar 3-month PDUFA extension before approval,” TG Therapeutics Chairman and CEO, Michael S. Weiss, said in the announcement.

According to the release, the submission of the Biologics License Agreement (BLA) was based on the results of the phase 3, multicenter ULTIMATE I and II studies evaluating the efficacy, safety and tolerability of ublituximab in 1,094 patients with multiple sclerosis in 10 countries.

Participants were randomized to receive ublituximab (450 mg as a 1-hour intravenous infusion every 6 months, followed by a day 1 infusion of 150 mg every 4 hours and a day 15 infusion of 450 mg every 1 hour) or oral teriflunomide (14 mg tablet once daily).

According to the release, both studies met the primary endpoint with ublituximab showing a statistically significant reduction in annualized recurrence rates over a 96-week period compared to teriflunomide.

“We will continue to work with the FDA to complete the review of the ublituximab BLA and plan to be prepared and ready to proceed with approval,” Weiss said in the release.

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