Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended the granting of marketing authorization for Fabhalta (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who suffer from hemolytic anemia.

Clinical studies have shown that oral iptacopan demonstrated superior improvement in hemoglobin without the need for red blood cell transfusions compared to anti-C5 therapies, 'a potentially revolutionary benefit for people living with this chronic blood disorder', believes Antonio Risitano, President of the International PNH Interest Group.

' If approved by the European Commission, Fabhalta would be the first oral monotherapy available for HPN patients in Europe', said Patrick Horber president of Novartis.

'This oral therapy could be an indispensable alternative to support many people with HPN who often have to structure their lives around the management of their disease', she added.

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