US FDA modifies dosing for ESA's Aranesp, Epogen and Procrit on cardiovascular risks

The US Food and Drug Administration on Friday recommended more conservative dosing guidelines for erythropoiesis-stimulating agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis and death.

ESAs are approved to treat some forms of anemia resulting from CKD, chemotherapy and certain other conditions. Drugs in the ESA class are epoetin alfa, marketed as Epogen by Amgen (Nasdaq: AMGN) and Procrit by Johnson & Jonson (NYSE: JNJ) subsidiary Janssen under a licensing accord with Amgen, and darbepoetin alfa, marketed as Aranesp, also by Amgen. Both companies have revised prescribing information accordingly, they announced the same day.

Given that the FDA has previously flagged up concerns about ESAs (The Pharma Letter January 7 and October 25, 2010), Deutsche Bank analyst Robyn Karnauskas, quoted by The Associated Press, said most investors have already priced the labeling changes into sales expectations. Wall Street analysts generally expect sales of the drugs to decline by 8% in 2012, Mr Karnauskas said in an e-mail to AP.