Ultomiris Under Priority FDA Review as Potential gMG Treatment

Ultomiris Under Priority FDA Review as Potential gMG Treatment

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Ultomiris Under Priority FDA Review as Potential gMG Treatment

The U.S. Food and Drug Administration (FDA) has accepted and placed on priority review an application seeking the approval of Ultomiris (ravulizumab-cwvz) to treat adults with generalized myasthenia gravis (gMG). The FDA set April through June as a target date range for its decision. Ultomiris is a monoclonal antibody that is designed to block the activation of the complement cascade, a part of the immune system thought to drive gMG. Developed by Alexion Pharmaceuticals, now…

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