Aspaveli - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

pegcetacoplan

Opinion

On 11 December 2025, 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 Aspaveli. The marketing authorisation holder for this medicinal product is Swedish Orphan Biovitrum AB (publ).

The CHMP adopted a new indication, as follows:

Aspaveli is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.

Aspaveli is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.

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

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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Aspaveli (EMA/VR/0000248937)

Adopted Reference Number: EMADOC-1700519818-2607912

Key facts

• Name of medicine:
  Aspaveli
• EMA product number:
  EMEA/H/C/005553
• Active substance:
  pegcetacoplan
• International non-proprietary name (INN) or common name:
  pegcetacoplan
• Therapeutic area (MeSH):
  Hemoglobinuria, Paroxysmal
• Anatomical therapeutical chemical (ATC) code:
  L04AJ03
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• 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.

• Marketing authorisation holder:
  Swedish Orphan Biovitrum AB (publ)
• Date of opinion:
  11/12/2025
• Status:
  Positive