TG-1101 and TG-1202 Combo receives orphan drug designation: FDA

Release Date: 10-Jan-2017

TG Therapeutics, a biopharmaceutical company focused on developing medication and therapies for the treatment of rare and deadly diseases has announced that Food and Drug Administration in US has granted orphan drug status to the combination of its leading products TG-1101(ublituximab), the Company's novel, glycoengineered anti-CD20 monoclonal antibody and TG-1202, the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL). The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL as well as the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).


The FDA's designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of US marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval


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