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# FDA Extends Review of Multiple Sclerosis Therapy
- URL: https://www.fdaweb.com/fda-extends-review-of-multiple-sclerosis-therapy/
- Published: 2022-05-31T12:00:00.000Z
- Updated: 2026-09-14T17:46:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151937

FDA has extended by three months its review of a TG Therapeutics BLA for ublituximab, indicated for treating patients with relapsing forms of multiple sclerosis (RMS). The revised user fee review action target date is 12/28.

The review extension is intended to give the agency additional time to review an information request that was deemed a major amendment. The submission includes an integration and summary of certain clinical information that was previously provided to the agency, the company says. The BLA submission was based on the results from the ULTIMATE I & II trials, two identical Phase 3, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with RMS.

Ublituximab is described as 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, the company says. “Additionally, ublituximab 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.”