Once again, FDA's experts will wrangle over safe use of Amgen and Johnson & Johnson's blockbuster anemia drugs. In the wake of a study that raised new questions about the safety of Amgen's Aranesp, the agency is convening an advisory panel for advice on changing the anemia drugs' labeling to restrict their use in kidney patients who aren't yet on dialysis.
The study in question, TREAT, aimed to show that Aranesp helped predialysis kidney patients. It didn't. Instead, it showed a higher risk of stroke and death in kidney patients who had a history of cancer, Reuters reports. Aranesp's sister drug, Epogen, is typically used in kidney patients already on dialysis; J&J sells it under the brand name Procrit for kidney and cancer patients.
Amgen EVP Roger Perlmutter told Reuters that the company has already proposed label changes that would limit Aranesp use: "We're concerned, and we don't want to see these drugs overused," he told the news service.
This is just the latest confab over proper use of these high-tech anemia drugs. In 2007, FDA put dosing restrictions on the drugs when used in cancer patients; their labels have been updated several times since, including new guidelines added earlier this year. They're still big sellers--with $4.5 billion in expected 2010 sales--but they aren't as big as they used to be. Sales peaked at some $10 billion in 2006, before the first big safety debate.