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The FDA has set a Prescription Drug User Fee Act goal date of Sept. 28, 2022.
The FDA has accepted TG Therapeutics’ biologics license application (BLA) for ublituximab, an investigational glycoengineered anti-CD20 monoclonal antibody to treat patients with relapsing forms of multiple sclerosis (RMS).
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of Sept. 28, 2022, TG Therapeutics said in a statement. The FDA is not planning to hold an advisory committee meeting to discuss the application.
The submission was based on the results of two identical phase 3, randomized, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared with Sanofi Genzyme’s Aubagio (teriflunomide).
Both studies met their primary end point with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate compared with Aubagio over a 96-week period.
“This is a major milestone for us as it is our first U.S. marketing application for an autoimmune indication. We look forward to working with the FDA throughout this review process,” said Michael S. Weiss, chairman and CEO of TG Therapeutics.
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells, TG Therapeutics said.
When ublituximab binds to the B-cell it triggers a series of immunological reactions, including antibody-dependent cellular cytotoxicity and complement dependent cytotoxicity, leading to destruction of the cell.
In addition, the drug is “uniquely 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,” TG Therapeutics said.