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EMA Product

Voydeya

Product approved by European Medicines Agency (EU)

Basic Information

Voydeya

Regulatory Information

EMEA/H/C/005517

Authorised

April 19, 2024

February 22, 2024

1

February 27, 2025

Company Information

France

103-105 rue Anatole France 92300 Levallois-Perret

Alexion Europe SAS

Drug Classification

Orphan MedicineAdditional Monitoring

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication 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

Overview Summary

Voydeya is a medicine used in adults to treat paroxysmal nocturnal haemoglobinuria (PNH), a disease in which excessive breakdown of blood cells results in anaemia (low levels of red blood cells), thrombosis (blood clots in blood vessels), pancytopenia (low levels of blood cells) and dark urine (due to large amounts of haemoglobin - the protein in red blood cells that carries oxygen around the body - being released into the urine). Voydeya is used in addition to ravulizumab or eculizumab (other medicines for PNH) in patients who continue to have anaemia despite these treatments. PNH is rare, and Voydeya was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 December 2017. Further information on the orphan designation can be found on the [EMA website](https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-17-1946). Voydeya contains the active substance danicopan.

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