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EU approval for Novartis' Exjade

Published on 31/08/06 at 12:41pm

Novartis' new treatment for the rare and difficult to treat condition of transfusional iron overload has been approved in the EU.

Exjade (deferasirox) is the first oral iron chelator to be approved in Europe and offers the first once-daily treatment option to anaemia patients with excess iron resulting from blood transfusions.

Chief executive and president of Novartis Oncology David Epstein said: "The approval of Exjade starts a new era in treating iron overload by providing effective continuous chelation coverage that is easy for patients to use.

"The introduction of this innovative product continues the decades-long support and leadership Novartis has brought to the iron chelation community."

Until now, the mainstay of treatment for transfusional iron overload has been Novartis' Desferal (desferioxamine), an inconvenient infusion via needle that is administered over a period of eight to 12 hours, five to seven times a week.

In contrast, Exjade tablets are dispersed in a glass of water or orange juice and taken once a day. Novartis estimates peak annual sales for the drug to reach $400 million, assuming it replaces Desferal.

Granted orphan drug status in 2002, Exjade was approved in the EU on the basis of clinical trials involving more than 1,000 patients. These showed Exjade was as effective as Desferal at reducing the body iron burden as measured by liver iron content.

Mild, non-progressive increases in serum cretonne levels, which indicate an abnormal kidney function, were observed in about one-third of patients taking Exjade.

The increases were mostly within a normal range and often resolved spontaneously or were alleviated by reducing the dose of the drug, Novartis said.

Nevertheless, patients will need to have their liver function assessed before commencing Exjade treatment, and it should subsequently be monitored on a monthly basis.

Exjade is indicated in the EU for the treatment of chronic iron overload due to frequent blood transfusions in patients aged six and older with beta thalassemia, a type of anaemia.

It is also indicated for use when Desferal is contraindicated or considered inadequate in patients with other anaemias, in children aged two to five years and patients suffering from beta thalassemia major with iron overload due to infrequent blood transfusions.

Exjade also has orphan drug status in the US, where it was approved in November 2005 as the first oral iron chelator under the FDA's accelerated approval programme.

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