Oral treatment for chronic iron overload due to repeated blood transfusions approved by European Union

Exjade, a once a day oral chelator for the treatment of iron overload, a cumulative and potentially life-threatening consequence of frequent blood transfusions, has been approved for use in all 25 member states of the European Union.

Earlier this year, Exjade was approved to be released in the UAE following approval by the US Food and Drug Administration (FDA) and Swiss medics.

Iron chelation is often necessary to prevent potentially life-threatening complications of excess iron in patients who receive regular blood transfusions for diseases such as thalassemia, myelodysoplastic syndromes, sickle cell disease and other anemias.

A single dose of Exjade works throughout the day, removing excess iron including highly toxic labile plasma iron, from key organs such as the liver and heart.

The single daily dose negates the use of the cumbersome infusion pump which can take from eight to 12 hours for five to seven nights a week while the patient continues to receive blood transfusions or has excess iron within the body.

"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," said David Epstein, CEO and President, Novartis Oncology.

The clinical trials of Exjade were part of the largest prospective global clinical trials programme ever implemented for an investigational iron chelator. Data involving more than 1,000 patients with a broad range of underlying diseases demonstrated that Exjade is effective at managing and reducing body iron burden, particularly in patients with moderate to severe iron overload.