A decision Tuesday by an FDA panel was seen as a win for Johnson & Johnson and Amgen, as it voted 14-5 against setting a new restriction for the use of anemia drugs in kidney failure patients. Marketed as Epogen/Aranesp by Amgen and Procrit by J&J, the drugs have been the target of safety concerns when given in high doses, and already carry the agency's strictest "black label" (full story). A determined ceiling would have led to a decrease in the amount of medication doctors could give to their patients. Nevertheless, doses are unlikely to return to levels seen before the safety concerns emerged. Despite the vote, however, several members of the panel said they supported small trims or adjustments that might effectively reduce the recommended dosage by at least a slight amount. An FDA official said the agency hopes to finalize changes, that would include the committee vote and an earlier one by the agency's cancer-drug advisers, to the drugs' labels in "weeks, not months."
Sources: Wall Street Journal, New York Times
Commentary: Johnson & Johnson's Suit Against Amgen: An Act of Desperation • Amgen Takes Hit on Storm Clouds
Stocks/ETFs to watch: JNJ, AMGN
Seeking Alpha's news briefs are combined into a pre-market summary called Wall Street Breakfast. Get Wall Street Breakfast by email -- it's free and takes only seconds to sign up.
