Blood Products Advisory Committee (BPAC) of the US Food and Drug Administration (FDA) gave a positive review of Norvatis Corporation's Exjade (deferasirox).

Exjade is currently under priority review by the FDA as the first and only once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusions in adults and children. If approved, Exjade may be a major advance in iron chelation therapy in the US, informs a company release.

Exjade, which has been designated an orphan drug in both the EU and the US, is currently under priority review in the US, Canada, Switzerland, Australia and New Zealand. Additional regulatory submissions have been filed around the world.

The Exjade filings were based on the results of a pivotal clinical trials program, including a Phase III head-to-head trial vs. Desferal (deferoxamine), which showed that Exjade significantly reduced liver iron concentration (LIC) at doses of 20-30 mg/kg/day.