FDA Finds Injectable Anemia Drug 'Not Approvable'


OB.GYN. NEWS and “The Pink Sheet” are published by Elsevier.

The Food and Drug Administration has issued a “not approvable” letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.

The Daiichi Sankyo Co. subsidiary said in a statement on March 12 that the studies are needed to address safety issues with Injectafer, particularly a mortality signal that led the Drug Safety and Risk Management Advisory Committee to vote against its approval in February.

The panel concluded that studies conducted by Shirley, N.Y.-based Luitpold Pharmaceuticals Inc. showed that Injectafer was efficacious in replenishing iron and improving hemoglobin concentration, but the mortality data raised a red flag—10 deaths of patients who received the drug, 5 of whom had cardiac abnormalities.

A number of committee members advised that if the FDA chose to approve the product, the label should be limited to women for whom oral iron is not effective. Most of those voting in favor of approval said off-label use should be limited, especially in chronic kidney disease patients.

“While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA's concerns,” Mary Jane Helenek, Luitpold's president and CEO, said in the company release.

The not approvable letter is the second received by the company related to the mortality signal. Luitpold submitted a statistical assessment of mortality data, study reports for two additional studies, and responses to other FDA questions in September 2007.

The company said its application includes data from 12 multicenter trials including more than 3,000 patients.

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