FDA announces orphan drug designation for TG-1101 for NMO and NMOSD

Release Date: 11-Nov-2016

TG Therapeutics Inc., a biopharmaceutical company  focusing on developing and commercializing the medicines or treatments for B-cell malignancies and auto-immune diseases, developed TG-1101 (ublituximab), the company’s novel products has been designated as orphan drug by Food and Drug Association (FDA) for the treatment of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD). Presently, there are no other FDA approved treatment options available in the market for NMO and NMSD. TG-1101 is the glycol-engineered anti-CD20 monoclonal antibody and a non-oncology indication providing additional protection.

Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) are also called as Devic’s disease. It is an immune related chronic inflammatory disorder involving different parts of the central nervous system, primarily damaging optic nerve and spinal cord. The affected optic nerve and spinal cord causes loss of swelling and inflammation in eyes, vision and pain weakness or paralysis in the legs or arms, loss of sensation, and problems with bladder and bowel function. The disease rarely possess its progressive phase.

FDA grants orphan drug status for rare and life threatening diseases that affect less than 200,000 people per year in the U.S. Also, FDA provide several beneficiaries to drug developers including assistance with clinical study design and drug development, tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

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