TG Therapeutics Gets Orphan Drug Status for Monoclonal Antibody


TG Therapeutics, Inc. announced today the U.S. Food and Drug Administration (FDA) has conferred two orphan drug designations for ublituximab (TG-1101), the Company's novel, glycoengineered anti-CD20 monoclonal antibody.

One is for the treatment of Nodal Marginal Zone Lymphoma, and one is for Extranodal Marginal Zone Lymphoma (Mucosa-Associated Lymphatic Tissue, or MALT lymphoma).

Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma are very rare subtypes of B-cell non-Hodgkin's lymphoma.

The FDA's Office of Orphan Drug Products extends orphan drug designation to drugs or biologics believed to be novel potential therapies that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S.

Orphan drug designation grants the developer a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication, or if it demonstrates superior safety, efficacy or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. Designation also grants the developer 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.

Source: MarketWatch

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