New NMOSD drug approved by the FDA

Inebilizumab (Uplizna) has been cleared for neuromyelitis optica spectrum disorder (NMOSD). The monotherapy drug is now the first and only B cell-depleting antibody approved for the disease.

Manufactured by Viela Bio, inebilizumab is designed to reduce the risk of NMOSD attacks in adults who are anti-aquaporin-4 (AQP4) antibody positive with a twice-a-year maintenance regimen after 2 loading doses. The approval comes less than a year after the FDA approved the first NMOSD drug, eculizumab (Soliris).

“Uplizna is an important new treatment option that provides prescribing physicians and patients living with NMOSD a therapy with proven efficacy, a favorable safety profile and a twice-a-year maintenance dosing schedule,” said Bruce Cree, MD, PhD, a neurologist from the University of California, San Francisco. Cree was lead investigator of the N-MOmentum trial, the largest NMOSD study to-date that contributed to inebilizumab’s approval.

In the 230-participant, double-masked, multicenter trial, patients were randomized to 2 initial doses of 300 mg intravenous inebilizumab or placebo and were given an option to receive additional doses every 6 months. Results published in The Lancet showed that 89% of anti-AQP4 antibody positive individuals remain relapse-free 6 months after treatment compared with 58% of placebo controls. The treatment also reduced the number of NMOSD-related hospitalizations and touted a favorable safety and tolerability profile. The most common adverse events were urinary tract infection, nasopharyngitis, infusion reaction, arthralgia and headache.

Viela Bio, which is based in Maryland, hopes to launch their product later this month.