TG Therapeutics Gets Orphan Drug Status For Anti-inflammatory Drug

TG Therapeutics, a New York-based clinical-stage biopharmaceutical company, has been granted orphan drug status by the US Food and Drug Administration (FDA) for ublituximab, an anti-inflammatory drug. Ublituximab is a glycol-engineered anti-CD20 monoclonal antibody for treating patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD). There are currently no FDA approved treatments for NMO or NMOSD, according to the company.

NMO and NMOSD, also known as Devic’s disease, is an immune-mediated severe chronic inflammatory disorder with involvement of different regions of the central nervous system that primarily affects the optic nerve and the spinal cord. The damage to the optic nerves produces swelling and inflammation that cause pain and loss of vision while damage to the spinal cord causes weakness or paralysis in the legs or arms, loss of sensation, and problems with bladder and bowel function. NMO is a relapsing-remitting form of autoimmune disease, similar to multiple sclerosis. However, unlike MS, progressive phase of this disease is very rare.

Source: TG Therapeutics

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