FDA COMMITTEE TO REVIEW NOVARTIS' EXJADE

The FDA's Blood Products Advisory Committee will meet Sept. 29 to review Novartis' new drug application (NDA) for Exjade, which could replace a much more difficult treatment for patients suffering chronic iron overload from blood transfusions.

Patients with certain types of anemia, sickle cell disease and other conditions require frequent blood transfusions, which can cause iron overload. Exjade (deferasirox) is an iron chelator, a drug used to remove excess iron from the body.

Novartis is touting Exjade as the replacement for its iron overload treatment Desferal (deferoxamine). Exjade is a dissolving tablet taken once a day in a glass of water or orange juice, whereas Desferal must be injected via a portable pump for eight to 12 hours a day, five to seven days a week, as long as the patient receives blood transfusions.

Novartis submitted its NDA May 3 and was granted a priority review by the FDA, meaning the agency must make a decision on the drug by Nov. 3. The FDA grants priority review to products that would be a significant improvement over current products that treat, prevent or diagnose a disease.

One potential problem for Exjade is that in clinical trials, Exjade demonstrated non-inferiority to Desferal in 20- to 30-mg dosages, but not in 5- to 10-mg dosages, Novartis said in January.