Amgen’s, J&J’s Anemia Drugs Face FDA Advisory Review

Jan. 7 (Bloomberg) -- Amgen Inc. and Johnson & Johnson face a review of their top-selling anemia drugs by an advisory panel for the U.S. Food and Drug Administration.

The FDA will ask its advisers to evaluate whether lower doses would avoid increased risks of blood clots and heart attacks in patients with chronic kidney disease. The panel was announced in a New England Journal of Medicine commentary.

Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit are known as erythropoiesis-stimulating agents, or ESAs, and are used to boost levels of hemoglobin, an element of red blood cells. Sales of the Amgen anemia drugs fell 15 percent to $5.6 billion in 2008 from their high in 2006 after cardiovascular risks began to emerge in 2007.

“Randomized trials have endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes,” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, and his colleagues wrote in the commentary. “Unfortunately and unexpectedly, all results have suggested the opposite.”

The advisory committee meeting “will provide an opportunity to discuss the latest evidence on the benefits and risks of ESAs for patients with chronic kidney disease,” Amgen spokeswoman Emma Hurley said yesterday in an e-mail. The company has already updated prescribing information for its anemia drugs to highlight the risks, she said.