FDA panel gives surprise OK to Amgen and J&J

Government advisors support keeping anti-anemia drugs from Amgen and Johnson & Johnson on the market for chemo patients.

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By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- In a surprise decision, a panel of advisors for the Food and Drug Administration supported keeping anti-anemia drugs from Amgen and Johnson & Johnson on the market for use in cancer patients, according to Amgen.

The advisors voted 13-1 to keep Amgen's (AMGN, Fortune 500) Aranesp and J&J's (JNJ, Fortune 500) Procrit on the market for use with chemotherapy, said Amgen. The drugs are used to keep blood cell count from dropping and are often used with chemo, which can cause anemia in patients.

It was welcome news for both companies, and both stocks closed up higher in Thursday trading. Billions of dollars in annual sales stem from the use of these drugs in chemo patients.

But while Amgen and J&J dodged the biggest bullet - a recommendation to remove its drugs from use in chemo patients - the advisors voted in favor of making various changes to the safety labels on the drugs, reflecting the risks in various types of cancer. This could result in tougher warnings, in addition to the changes already made over the last year.

FDA spokeswoman Susan Cruzan said that FDA regulators will now consider the vote results and data to "determine the next step as to restrictive indication."

Amgen spokesman David Polk said in an email that "Amgen takes very seriously the safety signals seen in recent trials" of these drugs, known as erythropoiesis-stimulating agents or ESAs.

"We are committed to working with the FDA to consider the input from the committee and to implement future label changes," he said.

Dr. Jay Siegel, research and development group president for Ortho Biotech, the J&J subsidiary that produces Procrit, said in an email that his company has "provided the FDA with substantial new data that give important insight into the safety of ESAs. We hope that the FDA will now take time to review this substantial body of data before reaching its final decision."

Chemo-related sales are major sales-drivers for both companies. Aranesp sales totaled $3.6 billion in 2007, with more than $2 billion related to cancer. J&J said at least half of Procrit's $1.7 billion in U.S. sales last year was related to cancer treatment.

Amgen's stock has lost a quarter of its value over the last year, as the FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels.

J&J, which sells drugs, medical devices and consumer products, seems to be more insulated from the problem.

"Johnson & Johnson isn't as reliant on this franchise as Amgen," said Michael Krensavage, analyst for Raymond James. "The diversity of Johnson & Johnson helps shield it from the Procrit problems."

The FDA has focused its concern on study results showing an increased risk of death and tumor growth in chemo patients taking the anti-anemia drugs. These increases have been seen in various types of cancer, including breast, lymphoid, cervical, head and neck, and the "non-small cell" type of lung cancer, said the FDA.

The outcome of advisory votes is not a certainty. The non-binding votes are taken as suggestions by FDA regulators, who usually follow the advice of the panels when making regulatory decisions. To top of page

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