FDA grants orphan drug designation to TG’s TG-1101

TG Therapeutics Inc. recently announced that it has received orphan drug designation for TG-1101, otherwise known as ublituximab, from the U.S. Food and Drug Administration (FDA).

TG-1101 is TG’s novel, glycoengineered anti-CD20 monoclonal antibody for the treatment of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD).

“We are pleased to announce our first orphan drug designation for TG-1101 in a non-oncology indication, providing additional proprietary protection for TG-1101, which has a composition of matter patent in the U.S. through mid-2029, exclusive of patent term extensions,” TG Therapeutics Executive Chairman and Interim CEO Michael S. Weiss said. “As demonstrated with the announcement earlier this week of the orphan drug designation for TGR-1202 in the treatment of CLL (chronic lymphocytic leukemia), we are committed to building strong proprietary protection around our key compounds, which includes a multi-level patent strategy and orphan drug designations where appropriate. NMO is closely related to multiple sclerosis, an area of significant interest to us. We look forward to presenting early data from our current Phase 1b study of TG-1101 in NMO at the ECTRIMS (European Committee for the Treatment and Research in Multiple Sclerosis) conference this September, which we believe will provide an early peek into the effects of TG-1101 in patients with autoimmune diseases.”