Soliris

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eculizumab

Authorised
This medicine is authorised for use in the European Union.

Overview

Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).

These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. PNH results in anaemia (low red blood cell counts), thrombosis (blood clots in the blood vessels), pancytopenia (low counts of blood cells) and dark urine, while aHUS results in anaemia, thrombocytopenia (a decrease in the number of platelets, components that help the blood to clot) and kidney failure.

Soliris is used to treat adults with myasthenia gravis (a disease where the immune system attacks and damages muscle cells causing muscle weakness), in whom other medicines do not work and who have a specific antibody in their body called AChR antibody.

Soliris is also used to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a disease where the immune system damages nerve cells causing problems mostly with the optic (eye) nerve and the spinal cord. It is used in patients who have an antibody called AQP4 and whose disease is relapsing (where the patient has attacks [relapses] between periods with no symptoms).

Soliris contains the active substance eculizumab.

These diseases are rare, and Soliris was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (PNH: 17 October 2003; aHUS: 24 July 2009; myasthenia gravis: 29 July 2014; NMOSD: 24 April 2019).

This EPAR was last updated on 30/10/2019

Authorisation details

Product details
Name
Soliris
Agency product number
EMEA/H/C/000791
Active substance
Eculizumab
International non-proprietary name (INN) or common name
eculizumab
Therapeutic area (MeSH)
Hemoglobinuria, Paroxysmal
Anatomical therapeutic chemical (ATC) code
L04AA25
Accelerated assessmentAccelerated 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.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Alexion Europe SAS
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
20/06/2007
Contact address

103-105 rue Anatole France
92300 Levallois-Perret
France

Product information

26/08/2019 Soliris - EMEA/H/C/000791 - II/0105

Contents

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Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

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).

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.

Assessment history

Changes since initial authorisation of medicine

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