AstraZeneca PLC (AZN.L, AZN) has announced that their product, Voydeya, is recommended for marketing authorisation in the European Union. It is used as an additional treatment to ravulizumab or eculizumab for adult patients suffering from paroxysmal nocturnal haemoglobinuria, who also have residual haemolytic anaemia. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has formed a positive opinion of Voydeya based on the results from the pivotal ALPHA Phase III trial.
Voydeya has also been granted the Breakthrough Therapy designation by the FDA and PRIME status by the EMA. Recently, Japan has given approval for Voydeya, according to the company.
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