You Call That Efficacy? FDA Warns Amgen For Aranesp Promotion

For the past dozen years, Amgen has been marketing Aranesp to treat anemia caused by chronic kidney disease. So by now, one might expect the biotech to know how to successfully compile promotional material that is distributed to physicians. But apparently not, at least according to the FDA, which last week sent a letter chastising Amgen for committing some basic mistakes. What went wrong? The Amgen mailer omitted important risk information, suggested that Aranesp is useful in a broader range of conditions or patients than has been demonstrated by evidence and made unsubstantiated efficacy claims, according to the November 19 letter from the FDA Office of Prescription Drug Promotion (here is the Aranesp mailer). For instance, the FDA notes that Amgen claimed Aranesp can provide a consistent and controlled rise in hemoglobin and the references used to support this assertion are two publications that outline pivotal studies used for winning FDA approval and for compiling the language in the prescribing information. But the rate of increase in hemoglobin was not an endpoint in any of the studies. A separate efficacy claim also prompted criticism for a similar reason. The mailer boasted that Aranesp treatment significantly reduced the need for red blood cell transfusions by 48 percent compared with a placebo for patients whose hemoglobin levels fell below a certain level. But the FDA disputed the contention and, again, chided Amgen for the reference used to bolster its claim. The ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs