WASHINGTON —The FDA approved intravenous inebilizumab-cdon (Uplizna) to treat adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.
NMOSD, a rare auto-immune disease in which the immune system attacks the optic nerves and spinal cord, causes attacks of optic neuritis and transverse myelitis, with approximately 50% of patients with the disease having permanent visual impairment and paralysis. In June 2019, the 4,000 to 8,000 U.S. patients with NMOSD who are anti-AQP4 antibody positive gained their first treatment option with eculizumab.
Now, with this new approval, adults with this disease have an additional treatment option.
This approval was based on the results of a clinical trial including 230 adult patients with NMOSD, 213 of whom were anti-AQP4 antibody positive. “During the 197-day study, the risk of an NMOSD relapse in the 161 anti-AQP4 antibody positive patients who were treated with [inebilizumab-cdon] was reduced by 77% when compared to the placebo treatment group,” the FDA explained. “There was no evidence of a benefit in patients who were anti-AQP4 antibody negative.”
The FDA noted that inebilizumab-cdon carries a warning for infusion reactions, hypogammaglobulinemia, and potential increased risk of infection, “including Progressive Multifocal Leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis.” The most common adverse effects associated with the drug include urinary tract infection, headache, arthralgia, nausea, and back pain. The agency warned that females of reproductive age should use effective contraception during treatment with inebilizumab-cdon and for six months after. In addition, women who are pregnant should not take the drug, as it can harm a developing fetus or newborn. “Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks prior to initiation of [inebilizumab-cdon],” the agency added.
Inebilizumab-cdon was granted an Orphan Drug designation; the drug is manufactured by Viela Bio.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 130
Topic ID: 82,130,730,130,192,725,240