Soliris

eculizumab

Opinion

On 25 July 2019, 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 a new indication 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).

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

Key facts

Name
Soliris
Agency product number
EMEA/H/C/000791
International non-proprietary name (INN) or common name
  • eculizumab
Active substance
  • Eculizumab
Therapeutic area
Hemoglobinuria, Paroxysmal
Accelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
25/07/2019
Company name
Alexion Europe SAS
Status
Positive
Application type
Post-authorisation

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