23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for Voydeya, the first oral treatment for patients with paroxysmal nocturnal haemoglobinuria who continue to have haemolytic anaemia despite treatment with a C5 complement inhibitor (eculizumab or ravulizumab).

EMA’s recommendation is mainly based on the results of a randomised, double-blind, placebo-controlled Phase 3 study in 86 patients with paroxysmal nocturnal haemoglobinuria and clinically significant evidence of residual haemolytic anaemia while on treatment with C5 complement inhibitors ravulizumab or eculizumab.

Read EMA press release