Officials from the U.S. Food and Drug Administration, writing in this week’s New England Journal of Medicine, are calling for a re-evaluation about how popular drugs like Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit are used in patients with chronic kidney disease.
FDA officials said they will convene a panel of outside experts later this year to re-examine the safety of these anemia drugs in light of previously disclosed studies which show that patients treated with anemia drugs are often at higher risk of strokes and heart attacks.
Similar advisory committees have already met over the past several years, leading FDA to add new safety warnings to the labels of anemia drugs and place restrictions on the use of anemia drugs in chronic kidney disease patients and in cancer patients.
Wall Street has largely factored in declining sales for Amgen’s leading anemia drug Aranesp when thinking about the biotech firm’s valuation. But the FDA’s call for a new advisory panel meeting, coupled with a similar meeting already scheduled by Medicare, does raise the risk that analysts may have to go back and lower Aranesp sales estimates again.
“We, and we think most investors, were not expecting this editorial nor another FDA advisory panel, and Amgen stock is likely to trade down on this news,” said Credit Suisse analyst Michael Aberman in a note to clients Thursday.
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