AEGiS-Reuters: US FDA, Biogen say skin drug not for HIV patients

Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.

US FDA, Biogen say skin drug not for HIV patients

Reuters NewMedia - November 10, 2005

WASHINGTON, Nov 10 (Reuters) - Biogen Idec Inc.'s (BIIB.O: Quote, Profile, Research) skin drug Amevive should not be used in patients who have HIV because it may speed up progression of the virus or cause more complications, the biotechnology company and U.S. health regulators said on Thursday.

Amevive, which is approved to treat moderate to severe chronic plaque psoriasis, can reduce the amount of certain white blood cells, Biogen and the Food and Drug Administration said on the agency's Web site.

"Biogen Idec, in consultation with FDA, is contraindicating Amevive in patients with HIV disease," the company said in a letter to doctors and other healthcare providers.

The letter, dated in October, said the decision was based on the drug's lowering effect on CD4+ T lymphocytes, a type of white blood cell.

It added the company "is committed to ensuring that Amevive is used safely and effectively." The drug brought in $40 million in 2004 sales.

Biogen's letter is online at http://www.fda.gov/medwatch/safety/2005/safety05.htm#Amevive.

Shares of the Cambridge, Massachusetts-based company were up 75 cents, or 1.8 percent, at $43.38 in afternoon trade on the Nasdaq.

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