FDA Extends PDUFA  Date for TG Therapeutics Inc’s (NASDAQ: TGTX) BLA On Ublituximab and Withdraws Ukoniq Clearance 

TG Therapeutics Inc. (NASDAQ: TGTX) has announced that the FDA has extended the Prescription Drug User Fee Act date for its Biological License Application for ublituximab for relapsing multiple sclerosis to December 28, 2022.

FDA extends PDUFA date for ublituximab

The FDA postponed the PDUFA deadline to give time to consider a report submitted by the company in reply to the FDA’s request for information that the FDA considered a material change. The submission included incorporating and reviewing clinical data that the TG Therapeutics had previously disclosed to the agency.

CEO Michael Weiss said, “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. 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 RMS.”

The ULTIMATE I & II trials, two similar Phase 3 randomized, double-blinded, multi-center, global, active-controlled studies comparing ublituximab versus teriflunomide in patients with RMS, were the basis for the BLA filing. The company plans to continue collaborating with the FDA to finalize the review of the BLA and be ready to launch ubiltuximab after approval.

FDA cancels approval of Ukoniq

Also, the company has indicated that the FDA has withdrawn its approval for its lymphatic cancer drug Ukoniq because of concerns about a high risk of death in those receiving the treatment. However, in February of last year, Ukoniq was given accelerated clearance in the US for treatment of adult individuals with marginal zone lymphoma who had previously undergone treatment and those with follicular lymphoma.

The FDA rarely withdraws approvals for drugs, but it has done so for cleared treatments under the accelerated approval designation in recent times. According to the FDA, based on reviewed clinical study data, it established that the risks associated with Ukoniq treatment outweighed the benefits.