Novartis' Exjade has received positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Exjade is used to treat chronic iron overload requiring chelation therapy when deferoxamine therapy is insufficient in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndromes.
According to the company, Exjade would be the first oral treatment in the European Union, to treat iron overload in patients with the mentioned types of thalassemia.
Novartis Oncology president Hervé Hoppenot said patients with NTDT have suffered the effects of iron overload without accurate diagnosis, clear treatment guidelines or approved oral therapies.
"The CHMP recommendation is an important step toward improving the outcomes of patients with this type of thalassemiam," Hoppenot added.