FDA requests additional information, extends goal date for application of MS treatment

The FDA has extended the Prescription Drug User Fee Act goal date to Dec. 28, for TG Therapeutics’ biologics license application of ublituximab for patients with relapsing forms of MS.

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

“While we are disappointed with the extension of our [Prescription Drug User Fee Act (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,” Chairman and CEO of TG Therapeutics, Michael S. Weiss, said in the release.

Per the release, the biologics license agreement (BLA) submission was based on results of the phase 3, multicenter ULTIMATE I and II trials which evaluated the efficacy, safety and tolerability of ublituximab in 1,094 patients with relapsing MS in 10 countries.

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

According to the release, both studies met the primary endpoint with ublituximab demonstrating a statistically significant reduction in annualized relapse rate over a 96-week period compared with 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 launch upon approval,” Weiss said in the release.