FDA panel votes to restrict anemia drugs

Look on the bright side: It could have been worse. An FDA advisory panel voted to keep Amgen and Johnson & Johnson's anemia remedies on the market for cancer patients. So the drugs appear to have dodged the feared silver bullet, an outright revocation of that indication; FDA generally follows its panels' advice, but isn't required to.

The bad news--and there is bad news--is that the drugs' use could be severely limited. The panelists voted to restrict them to patients with uncurable cancers. Under the recommendations, the drugs wouldn't be approved for patients with breast cancer or with cancers that affect the head-and-neck region; studies show it's those patients that are most at risk for severe side effects, which include accelerated tumor growth and shortened survival.

One analyst estimated that the restrictions could shave off 40 percent of Aranesp's sales. Another said Amgen and J&J each would lose about a third of their market in cancer patients. Amgen, of course, is more dependent on the drugs; Aranesp is its top seller, and together Aranesp and Epogen (marketed mostly for kidney patients) account for $6.3 billion in sales. J&J's Procrit brought in $2.9 billion last year, but that's just a small fraction of the mega-pharma's $63.6 billion in overall revenues. Sales of the drugs had already been dropping because of safety concerns, prompting job cuts at both Amgen and J&J.

What's next? FDA will have to mull the panel's choices and make its own decisions. Then we'll be watching Medicare to see if it sharply restricts reimbursements for the drugs' use in cancer patients.

- check out the Los Angeles Times story
- read the New York Times article
- see the Forbes market report

ALSO: Yesterday, we reported that J&J CEO William Weldon chalked up $25.1 million in pay last year, relying on the Associated Press' calculations. Well, the Wall Street Journal comes up with a different figure, and it's even more eye-popping: $31.9 million. Report

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Amgen in new talks over ESA safety. Report
Medicare upholds anemia drug cuts. Report
Epogen/Aranesp-Top 10 Warnings and Recalls. Report