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AstraZeneca PLC on Friday said its Ultomiris drug has been approved in the EU to treat myasthenia gravis, a condition which causes muscle weakness.
Cambridge, England-based pharmaceutical firm AstraZeneca said Ultomiris, whose generic name is ravulizumab, is the first and only long-acting C5 complement inhibitor for the treatment of gMG in adults, who are anti-acetylcholine receptor antibody-positive.
The EU backing followed a 'positive opinion' received from the European Medicines Agency's Committee for Medicinal Products for Human Use.
Based on results from the Champion-mg Phase III trial, the drug was found to be ‘superior’ to a placebo.
‘We're proud to offer a new treatment option that provides more convenience in dosing and has shown clinical benefit in a broader range of patients, including those who remain symptomatic despite their initial standard of care treatment,’ said Marc Dunoyer, chief executive of Astra unit Alexion.
gMG is a rare autoimmune disorder characterised by loss of muscle function and severe muscle weakness. It can occur at any age, but it most commonly begins for women before the age of 40 and for men after the age of 60.
The approval came after AstraZeneca on Wednesday said its Tezpire severe asthma treatment has been approved in the EU.
Shares were up 1.0% at 10,028.00 pence each on Friday morning in London.
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