AstraZeneca: Voydeya approved as treatment for HPN in EU

(CercleFinance.com) - AstraZeneca announces that Voydeya (danicopan) has been approved in the European Union (EU) as an adjunct to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia.


Voydeya is a vaccine developed as an adjunct to Ultomiris (ravulizumab) or Soliris (eculizumab) to address the needs of around 10-20% of patients with PNH who develop clinically significant extravascular hemolysis (EVH) during treatment with a C5 inhibitor.

The European Commission (EC) approval follows a positive opinion from the Committee for Medicinal Products for Human Use, and is based on the results of a pivotal Phase III trial.

Results from the 12-week primary evaluation period of the trial were published in The Lancet Haematology.


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