WASHINGTON, Nov. 9 (UPI) -- The Food and Drug Administration said Wednesday it has OK'd Novartis's Exjade, the first oral drug for chronic iron overload.
The orally administered iron chelator treats the condition that occurs in patients who have had multiple blood transfusions, the agency said.
Therapy for iron overload, which can damage the heart and liver, had previously required daily drug infusions, which can last 8 to 12 hours, FDA noted.
"Exjade provides a significant advantage to adults and children who suffer from iron overload due to multiple red cell transfusions. This oral therapy will allow greater patient compliance and will potentially reduce the complications of iron overload," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
Exjade was cleared for market under the FDA's accelerated approval program, which allows the agency to approve products for serious or life-threatening diseases based on early efficacy data, the agency said.
In 48-week studies, Exjade demonstrated reduction in liver iron concentration in adult and pediatric patients receiving red blood cell transfusions on an ongoing basis, the FDA said.
Exjade also got orphan drug status from the agency, giving the company six months' market exclusivity.
