FDA grants priority review for Novartis drug Exjade

The FDA grants priority review to products that could potentially offer a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease.

A novel, easy to administer oral iron chelator, Exjade is taken once daily, after dispersing tablets in a glass of water or orange juice.

The current standard of care in iron chelation, deferoxamine, also sold by Novartis under the brand name Desferal, is effective but typically requires subcutaneous infusion lasting eight to twelve hours per day, for five to seven days a week for as long as the patient continues to receive blood transfusions. In many patients, the need for transfusion and chelation therapy may be life-long.

Analysts predict Exjade will take over Desferal in terms of patient up-take and that Exjade could become a potential blockbuster, with sales reaching over one billion a year once FDA approval is given.

“The priority review by the FDA reflects the potential of Exjade to fulfill a significant unmet medical need for patients with chronic iron overload,” said Diane Young, vice president, global head of clinical development at Novartis Oncology.

By giving the treatment priority review status the FDA have committed themselves to making a decision within six months of the submission date, which for Exjade was in May 2005. At that time, Novartis also submitted registration applications for Exjade in Europe, Switzerland and Australia. Exjade has already been granted priority review in Australia and fast track status in Switzerland. Further, Exjade has received Orphan Drug status in the US, EU and Australia.