Novartis receives CHMP recommendation for Exjade approval

Novartis' new Exjade therapy for non-transfusion-dependent thalassaemia (NTDT) syndromes has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency has endorsed the drug for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in NTDT patients aged ten years and older.

If approved as expected, Exjade would become the first oral treatment in the EU specifically indicated for the treatment of iron overload in patients with these types of thalassaemia.

Clinical trial data has demonstrated the benefits of the drug in treating thalassaemia, a diverse group of genetic disorders that affect red blood cell production.

Herve Hoppenot, president of Novartis Oncology, said: "The CHMP recommendation is an important step toward improving the outcomes of patients with this type of thalassaemia."

This comes after the CHMP also recommended Novartis' new serogroup B vaccine Bexsero for approval earlier this week.