AstraZeneca: Voydeya Recommended For Approval In The EU By CHMP - Quick Facts

(RTTNews) - AstraZeneca PLC (AZN.L, AZN) announced Voydeya has been recommended for marketing authorisation in the European Union as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria who have residual haemolytic anaemia. The CHMP of the European Medicines Agency based its positive opinion on results from the pivotal ALPHA Phase III trial.

Voydeya has been granted Breakthrough Therapy designation by the FDA and PRIME status by the EMA. Voydeya was recently approved in Japan, the company noted.

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