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CORRECT: FDA casts mixed votes for anemia drugs, more restrictions imposed

March 13, 2008: 04:24 PM EST

(Corrects to remove reference to kidney cancer)

NEW YORK, Mar. 13, 2008 (Thomson Financial delivered by Newstex) -- A U.S. Food and Drug Administration advisory committee has voted to increase some restrictions Thursday on Amgen Inc.'s (NASDAQ:AMGN) and Johnson & Johnson's (NYSE:JNJ) anemia drugs for cancer patients, such as requiring patient signature and education to use the products.

Asked whether it recommends the Erythropoiesis-stimulating agents, or ESAs continue to be marketed as a treatment for anemia caused by cancer treatment induced anemia, the committee voted 13-to-1 in favor.

On a second question, the panel voted 6 in favor and 8 against having the current indications changed to restrict use to patients with small-cell lung cancer.

The panel voted to exclude patients with curable cancers by a margin of 11 to 2 with 1 abstention.

It voted 9 in favor and 5 against including a statement that ESA use is not indicated for patients with breast and/or head & neck cancers.

Considering whether the products' labeling should specify the hemoglobin level at which a patient should take an ESA, the committee said the decision was better left to treating physicians.

In order to minimize risks to chemotherapy patients, the panel voted in favor of requiring a cancer patient's authorization to undergo an ESA treatment, with both patient and doctor signatures required. Eight committee members voted in favor and 5 against with one abstention.

However, the committe voted against restricted distribution of the ESAs with 1 vote in favor, 10 against and 2 abstentions. Restricted distribution would have required identification and enrollment of healthcare providers who would agree to prescribe the products only in accordance with product labeling.

Shares of Amgen were up 4.7% at $47.12, but had been up as much as 7.9% in intraday trading. Johnson & Johnson, a component of the Dow industrials, tacked on 0.7% to $63, paring earlier gains of as much as 1.4%.

Michelle Rama


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