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Author: Admin | 2025-04-28
Myasthenia gravis by inhibiting the C5 protein in the terminal complement cascade in the human immune system. The FDA approval was based on positive results from a CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in the primary endpoint of change from baseline in activities of daily living in patients with myasthenia gravis.About UltomirisUltomiris is the first and only long-acting complement C5 inhibitor that provides immediate, complete and sustained complement inhibition. The drug works by inhibiting the C5 protein in the terminal complement cascade. When activated in an uncontrolled manner, the complement cascade overreacts, causing the body to attack its own healthy cells. Ultomiris acts as complement inhibition, and adult patients only need to inject Ultomiris intravenously every eight weeks.Ultomiris was first approved by the FDA in December 2018 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and children (one month and older) and was also approved in the European Union (EU) and Japan for the treatment of adults with PNH. It was also approved in the United States and Japan for treating atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and children (one month and older), while in the European Union, it was approved for aHUS treatment in adult and children patients weighing at least 10 kg. As part of an extensive development program, Ultomiris is being evaluated for the treatment of other hematological and neurological indications.Ultomiris came from AstraZeneca through its acquisition of Alexion. On December 12, 2020,
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