US seeks tough warning on Genentech asthma drug
Source: Reuters
(Adds details, updates shares, adds byline) By Susan Heavey WASHINGTON, Feb 21 (Reuters) - Genentech Inc's <DNA.N> asthma drug Xolair should carry the strongest warning possible about a potentially deadly reaction known as anaphylaxis, U.S. health regulators said on Wednesday. The Food and Drug Administration said anaphylaxis -- a severe allergic reaction -- occurs in about one in a thousand patients taking the medication, also known as omalizumab. It can lead to breathing problems, fainting and hives no matter what dose was given, the agency warned. Doctors and patients should be prepared to treat the reaction, which may occur as late as 24 hours after patients take Xolair. Despite the FDA's request for a so-called black box warning, Genentech said no decision had been made. The South San Francisco-based biotech said it was still discussing the matter with the FDA. "The updated wording and its placement in the label is not yet final," the company said in a statement. Shares of the drugmaker closed up 80 cents, or nearly 1 percent, at $87.74 on the New York Stock Exchange (NYSE). Genentech, the world's second-largest biotech, is majority-owned by Swiss drugmaker Roche Holding AG <ROG.VX>. Shares of Novartis AG <NOVN.VX><NVS.N>, which collaborates with Genentech to develop and market the drug in the United States, closed down 52 cents, or nearly 1 percent, at $58.17 also on the NYSE. Reports of the reaction to Xolair were seen in clinical trials before the drug was approved in 2003 to treat patients with allergy-related asthma, the FDA said. Continued reports of the problem after the drug hit the market prompted the agency's call for the tough warning given "their life-threatening potential, frequency, and the possibility for the delayed onset of anaphylaxis," the FDA added. Genentech and Tanox <TNOX.O> have been working with Novartis to develop and market Xolair, which CIBC World Markets analysts said saw U.S. sales of $108 million in the third quarter of 2006. In November, Genentech announced plans to buy Tanox in an effort to boost its income from Xolair. Novartis maintains control of the drug outside the United States in the 52 other countries where it is also sold. Along with Genentech, Novartis is also studying the drug's use in children ages 6 to 12 with moderate to severe persistent asthma. Genentech spokeswoman Tara Cooper said that trial was still ongoing.
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