Swiss pharma giant Novartis has won approval in the USA for Exjade (deferasirox), a novel iron chelator product that reduces the iron overload that can occur in patients who have to undergo multiple blood transfusions.
A number of diseases cause patients to require routine transfusions, including thalassaemia, sickle cell disease and various other forms of anaemia and myelodysplastic syndromes.
At present, the only product approved in the USA to remove excess iron is Novartis’ older iron chelator, Desferal (deferoxamine). But this product must be delivered via eight to 12-hour infusions - almost every day - so an orally active alternative is expected to appeal to patients and rapidly gain market share.
The new drug is administered as a once-daily drink made by dispersing the Exjade tablets in a glass of water or orange juice, said Novartis.
Desferal sales have stayed fairly flat over the last several years, bringing in upwards of $100 million dollars a year for the Swiss firm. But Exjade is thought to offer greater potential and should expand the market for iron chelators by extending treatment to patients unwilling to submit to the Desferal regimen, particularly children, according to Novartis
The Swiss firm said earlier this year that it was expecting peak sales of $650-$750 million for the new product [[23/06/05d]] [[03/05/05h]].
Exjade has been granted a priority review in Switzerland, Canada, Australia and New Zealand, and additional regulatory submissions have been made around the world, including in the European Union.