AstraZeneca GMG drug recommended for EU approval
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AstraZeneca said its treatment for the rare autoimmune neuromuscular disease generalised myasthenia gravis (GMG) has been recommended for marketing authorisation in the European Union as an add-on to standard therapy for adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.
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If authorised, Ultomiris would be the first and only approved long-acting C5 complement inhibitor for the treatment of AChR antibody-positive GMG in the EU, the company said on Monday.
GMG 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, it added.
“Initial symptoms may include slurred speech, double vision, droopy eyelids and lack of balance; these can often lead to more severe symptoms as the disease progresses such as, impaired swallowing, choking, extreme fatigue and respiratory failure.”
Reporting by Frank Prenesti at Sharecast.com