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AstraZeneca PLC on Thursday said its drug Ultomiris has been approved by the US Food & Drug Administration for the treatment of adults with generalised myasthenia gravis.
Myasthenia gravis is a long-term condition that causes muscle weakness. It commonly affects the muscles that control the eyes, facial expressions, and speaking.
Ultomiris, also known as ravulizumab-cwvz, treats patients who are anti-acetylcholine receptor antibody-positive, which represents 80% of people living with the condition, AstraZeneca explained.
US approval was based on positive results from a Champion-MG phase three trial, the Cambridge, England-based pharmaceutical company said. Results showed Ultomiris was better than a placebo in the primary endpoint of the trial.
AstraZeneca noted that this action by the FDA marks the first and only approval for a long-acting C5 complement inhibitor in the treatment of generalised myasthenia gravis.
Shares in AstraZeneca were up 0.3% at 10,542.00 pence each on Thursday morning in London.
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