Exjaded!

WASHINGTON -(Dow Jones)- The Food and Drug Administration raised safety questions Wednesday involving Novartis' proposed drug to help remove excess iron in patients undergoing regular blood transfusions as a result of anemia and other blood disorders.

The agency, in briefing documents released a day prior to a Thursday meeting about the drug, said it was concerned about possible kidney impairment and liver damage in some patients using the drug. The FDA has asked an outside panel of medical experts to make recommendations about whether the drug should be approved. The FDA typically follows its panels' advice but isn't required to do so.

The agency also raised concerns about whether Exjade was safe for long-term use in general population, given the trials involved about 800 patients and, among those, about 500 received Exjade. Most patients in the study received the drug for about a year, although some received Exjade for about three years. The drug would likely be used for longer than that by many patients.

UPDATE:

The Blood Products Advisory Committee (BPAC) of the FDA has given a positive review and unanimously voted to recommend approval for the use of Novartis' Exjade (deferasirox). The compound 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. Exjade, which has been designated an orphan drug in both the EU and the US, is also currently under priority review in Canada, Switzerland, Australia and New Zealand. Additional regulatory submissions have been filed around the world.