Voydeya

Opinion

EMA has issued an opinion on this medicine

Danicopan

Overview

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Voydeya¹, intended as add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria (PNH). The applicant for this medicinal product is Alexion Europe.

Voydeya will be available as 50 mg and 100 mg film-coated tablets. The active substance of Voydeya is Danicopan, a complement inhibitor (ATC code: L04AJ09) which reversibly binds to factor D to prevent alternative pathway-mediated haemolysis and deposition of complement C3 proteins on red blood cells, thereby helping to relieve the symptoms of PNH.

The benefit of Voydeya, when added to C5-inhibitor treatment, is its ability to prevent haemolysis and increase haemoglobin levels, as seen in a phase 3 randomised, placebo-controlled trial in patients with PNH and residual haemolytic anaemia. The most common side effects are pyrexia, headache, increased hepatic enzyme levels and pain in the extremities.

The full indication is:

Voydeya is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia

Voydeya should be prescribed by physicians experienced in the management of patients with haematological disorders.

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

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¹This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Voydeya

AdoptedReference Number: EMA/CHMP/63838/2024

Product details

• Name of medicine:
  Voydeya
• Active substance:
  Danicopan
• International non-proprietary name (INN) or common name:
  Danicopan
• Therapeutic area (MeSH):
  • Hemoglobinuria, Paroxysmal
  • Hemolysis
• EMA product number:
  EMEA/H/C/005517
• 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 applicant:
  Alexion Europe SAS
• Opinion adopted:
  22/02/2024
• Opinion status:
  Positive