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Ultomiris approved in the US for adults with generalised myasthenia gravis

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Published:29th Apr 2022

Ultomiris (ravulizumab-cwvz) has been approved in the US for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people living with the disease.

The approval by the FDA was based on positive results from the CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26, a patient-reported scale that assesses patients’ abilities to perform daily activities. This FDA action marks the first and only approval for a long-acting C5 complement inhibitor for the treatment of gMG.

Condition: Myasthenia Gravis
Type: drug

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