FDA to review anemia drug safety again

The FDA is once again wading into the safety data on Amgen's anemia drugs. An advisory committee will convene later this year to evaluate whether lower doses would help avoid increased cardiovascular risks for kidney patients, the agency announced in a New England Journal of Medicine commentary.

It's not good news for Amgen, or for Johnson & Johnson, which markets an Amgen-made drug of the same class. But it's not completely unexpected, either. Last fall, an NEJM-published study known as TREAT indicated that Aranesp not only didn't lower the risk of heart problems or death compared with placebo, but the stroke rate among Aranesp patients was about double that of the placebo patients.

As the New York Times points out, some considered the TREAT results to be reassuring--no increase in heart attacks for Aranesp patients, after all--the stroke numbers caused concern. In a recent commentary published by The Journal of the American Society of Nephrology, Dr. Ajay K. Singh of Harvard Medical School concluded that avoiding Aranesp--and its sister meds Epogen and the J&J-marketed Procrit--"is now the soundest approach given the remarkable observations from the Treat study."

And therein lies the probable change in use, analysts said. "I don't think it's a big deal," Cowen & Co.'s Eric Schmidt told Bloomberg. "The worst-case scenario is you get further restrictions on the use of ESAs in the pre-dialysis setting." Aranesp brought in $700 million from early stage kidney patients, the news service reports; overall, Amgen's anemia drug sales came in at $5.6 billion in 2008. So that market segment is a relatively small piece of the anemia-drug pie. But on top of previous declines in sales--that $5.6 billion is down 15 percent from the high-sales mark in 2006--it could still hurt.

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