Genentech (a Roche company) has announced that it has received approval from the FDA for Enspryng (satralizumab) to treat patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD). The drug is the first and only subcutaneous drug available to treat NMOSD.
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The approval is based on the two randomized Phase 3 trials, the SAkuraStar and SAkuraSky studies. Efficacy was measured after 96 weeks in both the studies, the first protocol-defined relapse (PDR) was the primary endpoint. There was a significant reduction in the risk of relapses compared to placebo as monotherapy when it was administered along with immunosuppressant therapy (IST).
In SAkuraStar monotherapy, 76.5% of the patients who were treated with Enspryng had no relapses after 96 weeks compared to 41.1% of patients in the placebo arm. In the SAkuraSky study, 91.1% of patients who were on Enspryng has no relapses after 96 weeks compared to 56.8% of patients who were on placebo.
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Enspryng is a humanized monoclonal antibody approved for treating the adult patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. The drug acts by targeting and blocking the interleukin-6 (IL-6) receptor activity, a critical mechanism that is believed to cause the inflammation in patients with NMOSD.
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Neuromyelitis optica spectrum disorder is a rare, chronic autoimmune disorder affecting the central nervous system. It damages the optic nerve and spinal cord, eventually leading to blindness, muscle weakness, and paralysis.
NMOSD impacted 10,000 patients in Europe, 15,000 patients in the United States, and 200,000 patients across the world.
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