CHMP extends existing indication of generalised myasthenia gravis to patients aged 6 years and above. -Alexion/AstraZeneca
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Soliris. The marketing authorisation holder for this medicinal product is Alexion Europe SAS/AstraZeneca.
CHMP adopted an extension to an existing indication of generalised myasthenia gravis for use in paediatric patients. For information, the full indications for Soliris will be as follows:i Soliris is indicated in adults and children for the treatment of: Paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history .ii. Atypical haemolytic uremic syndrome (aHUS).iii. Refractory generalized myasthenia gravis (gMG) in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive .
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