Uplizna FDA approval : US biotech company Viela Bio has secured approval from the US Food and Drug Administration (FDA) for Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease of the central nervous system (CNS).
The approval of Uplizna is for neuromyelitis optica spectrum disorder in adults who have a particular antibody called anti-aquaporin-4 (AQP4).
According to the FDA, neuromyelitis optica spectrum disorder primarily impacts the optic nerves and spinal cord. Apart from causing potentially irreversible blindness and paralysis, patients can also have loss of sensation, bladder and bowel dysfunction, nerve pain, and respiratory failure.
Uplizna is now only the second approved treatment for neuromyelitis optica spectrum disorder after Alexion Pharmaceuticals’ Soliris (eculizumab) in June 2019. Viela Bio was previously granted breakthrough therapy and orphan drug designations from the FDA for Uplizna for the rare neuroinflammatory autoimmune disease.
Commenting on Uplizna FDA approval, Bing Yao – CEO of Viela Bio: “We are proud that Viela Bio’s first approved medicine has the potential to help thousands of patients with NMOSD, a progressive and debilitating neuroinflammatory disease. We are incredibly grateful to the patients, families and care partners who participated in and supported our research.”
Uplizna FDA approval has been driven by the findings of the phase 2/3 N-MOmentum trial, which featured 230 adult patients. In the clinical trial, 213 of the 230 patients had antibodies against AQP4.
During the 197-day study, the risk of a relapse of neuromyelitis optica spectrum disorder in the 161 anti-AQP4 antibody positive patients who were subjected to Uplizna was brought down by 77% when compared to the placebo treatment group.
Bruce Cree – the lead investigator for the N-MOmentum clinical trial said: “NMOSD is an extremely challenging disease to treat. Patients experience unpredictable attacks that can lead to permanent disability from blindness and paralysis.
“In addition, each subsequent attack may result in a cumulative worsening of disability. In the pivotal N-MOmentum trial, UPLIZNA—a humanized CD19-directed monoclonal antibody—significantly reduced the risk of attacks and also reduced hospitalizations when given as a monotherapy.
“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.”