FDA Decision on Ublituximab for Relapsing MS Pushed to Year’s End

The U.S. Food and Drug Administration (FDA) is extending by three months its review of ublituximab, an experimental anti-CD20 antibody being developed by TG Therapeutics for relapsing forms of multiple sclerosis (MS).

The FDA had agreed to review the company’s application requesting ublituximab’s approval late last year, and initially planned to announce its decision by late September. That decision is now expected on Dec. 28.

This review extension follows an FDA request, called a major amendment to the application, for more information. It gives the agency sufficient time to review the information submitted, which included “an integration and summary of certain clinical information that was previously provided to the FDA,” TG Therapeutics said in a press release, without further details.

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“As we were targeting a launch for late this year or early next, we do not believe this will impact our overall launch plans for ublituximab in [relapsing] MS,” said Michael Weiss, chairman and CEO of TG Therapeutics.

“We will continue to work with the FDA to complete the review of the ublituximab BLA [biologics license application] and plan to be prepared and ready to launch upon approval,” Weiss said.

Ublituximab is an anti-CD20 monoclonal antibody that is designed to kill B-cells, a type of immune cell that plays a central role in the inflammatory attacks that drive MS. Two other anti-CD20 antibodies, Ocrevus (ocrelizumab) and Kesimpta (ofatumumab), are approved by the FDA to treat relapsing forms of MS, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

Notably, applications for both Ocrevus and Kesimpta underwent similar FDA review extensions.

“While we are disappointed with the extension of our PDUFA [Prescription Drug User Fee Act] 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,” Weiss said.

TG’s application seeking approval of ublituximab is supported by data from two Phase 3 clinical trials, ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248), which collectively enrolled over 1,000 people with relapsing MS.

Participants in the ULTIMATE trials were treated with ublituximab, given as an intravenous infusion, or with Aubagio (teriflunomide), an approved, oral MS therapy by Sanofi Genzyme. Results showed that ublituximab outperformed Aubagio at preventing relapses, reducing new brain lesions, and delaying disability accumulation.

“We believe ublituximab has the potential to offer [relapsing MS] patients a valuable treatment option that can be administered in a one-hour infusion every six months following the first dose,” Weiss said.