On 22 June 2023, 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.

The 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:¹

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 (see section 5.1).

• Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).
• Refractory generalized myasthenia gravis (gMG) in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).

Soliris is indicated in adults for the treatment of:

• Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1).
• Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease (see section 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

¹New text in bold, removed text as strikethrough