After winding down its oncology program to pivot to multiple sclerosis, TG Therapeutics has suffered a fresh setback as its lead candidate faces an additional three-month wait for an FDA decision.
The company originally expected the agency to make a call on its application for ublituximab to treat relapsing forms of MS by Sept. 28. But TG said Tuesday this date has been pushed back to Dec. 28.
The FDA needs the extra time to review TG’s response to an information request, which the regulator deemed a major amendment to the application. TG's submission comprised an integration and summary of certain clinical information previously provided to the FDA, TG said.
Ublituximab is a monoclonal antibody designed to target B cells—a type of white blood cell—that express a protein called CD20 as a way to manage B-cell malignancies and autoimmune disorders. The FDA has already approved two anti-CD20 medications for treating MS: Roche’s Ocrevus and Novartis’ Kesimpta.
TG will work with the FDA to complete the review and plans to be ready to launch ublituximab upon approval, CEO Michael Weiss said in a statement.
“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 three-month PDUFA extension prior to approval,” Weiss said. “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 company shifted its oncology program to the back burner in April in the wake of disappointing phase 3 trial results for a combination of ublituximab and TG’s approved cancer med Ukoniq in chronic lymphocytic leukemia. As a result of the study, TG removed Ukoniq from the market in two indications.
Instead, the biotech turned to its MS and autoimmune programs to buoy the business, led by the approval request for ublituximab for relapsing MS. The approval submission was based on data from two identical phase 3 studies, dubbed ULTIMATE I and II, which evaluated ublituximab compared to Sanofi’s Aubagio.