June 12, 2020

The U.S. FDA has approved Uplizna™ (inebilizumab-cdon), manufactured by Viela Bio, to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who test positive for the anti-aquaporin-4 (AQP4) antibody.

NMOSD, also known as Devic disease, affects 1–10 individuals out of every 100,000 people worldwide. This rare autoimmune disorder of the central nervous system is characterized by inflammation of the optic nerve and spinal cord. It tends to feature periods of relapse and remission, and in its early stages can be mistaken for multiple sclerosis. Signs and symptoms include pain inside of the eye, vision loss, pain in the spine and/or limbs, paralysis, and headaches. Some instances of NMOSD are associated with the presence of antibodies that bind to AQP4 proteins, which may activate the immune system and cause it to attack the central nervous system.

In a clinical study, Uplizna reduced the risk of an NMOSD relapse in anti-AQP4 antibody positive patients by 77% compared to placebo. However, it showed no evidence of benefit for patients who are not anti-AQP4 antibody positive.

The recommended initial dose is 300mg administered via intravenous (IV) infusion followed two weeks later by a second 300mg IV infusion. Subsequent doses should start six months from the first infusion and consist of a single 300mg IV infusion once every six months. Each infusion should take place over the course of 90 minutes, and patients must be closely monitored during the infusion and for at least one hour after the infusion.

Viela Bio has launched Uplizna at a wholesale acquisition cost (WAC) of $131,000 per three 100mg vials.

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