Orphan Drug Status Granted to Ublituximab for Two Neuromyelitis Disorders

The drug is for the potential treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder
The drug is for the potential treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder

The Food and Drug Administration (FDA) has granted Orphan Drug designation to TG-1101 (ublituximab; TG Therapeutics) for the treatment of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD).

NMO and NMOSD are immune-mediated severe chronic inflammatory disorders that affect the central nervous system, primarily the optic nerve and spinal cord. NMO is an autoimmune disorder similar to multiple sclerosis (MS), consisting of a relapsing-remitting phase. However, unlike MS, the progressive phase is very rare, so potential therapies under development aim to target the prevention of attacks. Currently, there are no FDA-approved treatments for NMO or NMOSD.

TG-1101 is currently being investigated in a Phase 1b study in patients with NMO. The Company expects to present preliminary data from this study at the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in September 2016.

TG-1101 (ublituximab) is a novel, glycoengineered anti-CD20 monoclonal antibody.

For more information visit TGTherapeutics.com.

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