The At its meeting in February 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the following two medicinal products for approval:
pegunigalsidase alfa (Elfabrio, Chiesi Farmaceutici)
Recombinant human α-galactosidase-A should be indicated as long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (alpha-galactosidase deficiency). Pegunigalsidase alfa is treated with orphan drug status.
Vadadustat (Vafseo, Akebia Europe)
The HIF prolyl hydroxylase inhibitor (HIF-PH inhibitor) should be indicated for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.
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Source — https://www.univadis.de/viewarticle/ema-empfiehlt-neue-arzneimittel-zur-zulassung-bei-morbus-2023a10004ds