(RTTNews) - AstraZeneca PLC (AZN.L, AZN) announced Ultomiris has been approved in Europe as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive. The approval follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the CHAMPION-MG phase III trial.
Marc Dunoyer, CEO, Alexion, said: "This approval in Europe of the first and only long-acting C5 inhibitor is an important step towards realising our vision of improving the lives of people living with gMG and increasing access to Ultomiris worldwide."
Ultomiris was approved in the US in April 2022 and Japan in August 2022 for certain adults with generalised myasthenia gravis.
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