TG Therapeutics confirmed that ublituximab, the company's novel, glycoengineered anti-CD20 monoclonal antibody has received two Orphan Drug designations from the U.S. Food and Drug Administration for the treatment of Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma, both rare subtypes of non-Hodgkin's lymphoma for which there are limited effective treatments. Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation potentially provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as potential tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act filing fees.
- Health Care Industry
- Marginal Zone Lymphoma