The US Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for ublituximab to December 28, 2022, as announced in a press release by TG Therapeutics.

Formerly known as TG-1101, ublituximab is an investigational monoclonal antibody to treat multiple sclerosis (MS). It targets CD20-expressing B-cells that are designed to elicit antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity.

The goal date for the Biologics License Application (BLA) was extended to allow time for the FDA to review additional information submitted by the treatment’s developer, TG Therapeutics, in response to a request by the FDA for more information. The additional information included integration and a summary of certain clinical information.


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“While we are disappointed with the extension of our PDUFA goal date for ublituximab, a delay of this duration is not unprecedented, with both of the currently marketed CD20s in MS experiencing a similar 3-month PDUFA extension prior to approval,” said Michael S. Weiss, chairman and chief executive officer of TG Therapeutics.

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“We will continue to work with the FDA to complete the review of the ublituximab BLA and plan to be prepared and ready to launch upon approval. We believe ublituximab has the potential to offer [relapsing forms of MS] patients a valuable treatment option that can be administered in a one-hour infusion every six months following the first dose,” Weiss added.

The BLA submission consisted of results from 2 identical phase 3 trials of ublituximab, Ultimate 1 (NCT0327726) and Ultimate 2 (NCT03277248). Both trials were randomized, double-blinded, global, active-controlled trials comparing ublituximab to teriflunomide in patients with relapsing forms of MS including relapsing-remitting MS and secondary progressive MS.

Between the 2 studies, a total of 1094 patients were enrolled across 10 countries. Both studies met their primary endpoint showing a significant reduction in annualized relapse rate compared to teriflunomide over a 96-week period (P <.05 in each trial).

The study compared a 1-hour intravenous infusion of 450 mg of ublituximab every 6 months (following a 4-hour infusion of 150 mg on day 1 and a 1-hour infusion of 450 mg on day 15) to 14 mg of teriflunomide taken daily, as well as matching placebos.

Reference

TG Therapeutics announces FDA extension of BLA PDUFA date for ublituximab to treat patients with RMS. News release. TG Therapeutics; May 31, 2022.