CMSC INforMS: Inebilizumab Approved for Treatment of Neuromyelitis Optica Spectrum Disorder
Thursday, June 11, 2020
Posted by: Elizabeth Porco
The treatment, marketed as Uplizna, is only the second approved therapy for NMOSD.
The US FDA has approved inebilizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. The intravenous therapy is only the second treatment approved for NMOSD.1
The drug, which will be marketed as Uplizna (Viela Bio), received breakthrough therapy designation2 from the FDA in April 2019 based on findings from the largest ever monotherapy study in this patient population.
The N-MOmentum study included 231 patients with NMOSD, including those with and without AQP4-IgG antibodies, which occur in about 80% of patients with NMOSD. Participants were randomly assigned to receive either 2 intravenous doses of inebilizumab monotherapy or placebo for a 6.5-month treatment period. The primary end point was time from treatment initiation to the occurrence of an NMOSD attack. Afterward, participating patients were allowed to enter an open-label extension in which all patients received the treatment every 6 months.
Over the course of the study, risk of NMOSD relapse was reduced by 77% in the treatment group compared with placebo. Notably, no benefit was observed in patients who were anti-AQP4 antibody negative.1
“Importantly, this trial studied inebilizumab as monotherapy, free from the confounding influence of other background immunosuppressive treatments,” Bruce Cree, MD, PhD, the lead investigator for the N-MOmentum study and professor of clinical neurology at UCSF Weill Institute for Neurosciences, said in a statement in January.3 “The results provide unambiguous evidence of a large reduction in the risk of attack. The results also showed a highly beneficial impact of inebilizumab on disability.”
The humanized, monoclonal antibody is designed to bind with high affinity to CD19 and deplete a broad range of B cells, including autoantibody-secreting plasmablasts and CD19-expressing plasma cells.
Notably, the prescribing information for Uplizna includes a warning for infusion-related reactions, risk of hypogammaglobulinemia, and increased infection risk, including progressive multifocal leukoencephalopathy, as well as reactivation of hepatitis B and tuberculosis. The most commonly observed adverse events are urinary tract infection, headache, joint pain, nausea, and back pain. Uplizna may cause harm to a developing fetus, so women who are pregnant should not take the drug. Women of reproductive age should use effective contraception while taking Uplizna and for the 6 months after treatment. In addition, it is not advised to receive live-attenuated or live vaccines during treatment with Uplizna. Administration of vaccines should be completed at least 4 weeks prior to treatment initiation.
1. FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord. News release. FDA. June 11, 2020. Accessed June 11, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord
2. Viela Bio Receives U.S. FDA Breakthrough Therapy Designation for Inebilizumab for Treatment of Neuromyelitis Optica Spectrum Disorder. News release. Veila Bio. April 18, 2019. Accessed April 18, 2019. businesswire.com/news/home/20190418005188/en/Viela-Bio-Receives-U.S.-FDA-Breakthrough-Therapy
3. Viela Bio Announces Inebilizumab Achieved Primary and Key Secondary Endpoints in Pivotal Trial in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD). News release. Veila Bio. January 3, 2019. businesswire.com/news/home/20190103005138/en/Viela-Bio-Announces-Inebilizumab-Achieved-Primary-Key
By: Alicia Bigica
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