TG Therapeutics : FDA Extends PDUFA Date For Ublituximab To Treat Patients With RMS

(RTTNews) - The U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) goal date to December 28, 2022, for the Biologics License Application or BLA for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis or RMS, TG Therapeutics Inc. (TGTX) said in a statement on Tuesday.

The FDA extended the PDUFA goal date to allow time to review a submission provided by the company in response to an FDA information request, which the FDA deemed a major amendment.

Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC), leading to destruction of the cell.

In addition, ublituximab is designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity.