FDA Asks Genentech To Add Boxed Anaphylaxis Warning To Xolair Label
This article was originally published in The Pink Sheet Daily
Executive Summary
Continued post-marketing reports of anaphylaxis, some well after treatment, led agency to ask for label revision.
|
Genentech is in discussions with FDA to update prescribing information for its asthma treatment Xolair (omalizumab) after the agency asked the company to add a boxed warning about anaphylaxis to the label and provide a medication guide for patients to strengthen existing anaphylaxis warnings, the company said Feb. 21. "Our next steps are really to talk with FDA further. Once those conversations have taken place and we've determined what the final label is going to look like, any other steps will be part of that discussion with FDA," the company told "The Pink Sheet" DAILY. Xolair was approved in 2003 to treat adults and adolescents with moderate to severe persistent asthma who test positive for a perennial aeroallergen, such as pollen, grass or dust, and whose symptoms are not controlled with inhaled steroids. As a result of postmarketing reports of anaphylaxis - which includes trouble breathing, chest tightness, dizziness, fainting, itching, hives and swelling of the mouth and throat - some occurring up to 24 hours after treatment, FDA asked Genentech to revise its label. The agency also issued an alert for health care professionals warning about the possibility of delayed anaphylactic reactions and advising them to educate patients on the danger. "Because of the chance of anaphylaxis with Xolair, patients should receive Xolair treatment in a doctor's office and be observed for at least two hours after each treatment," FDA says in the alert. "Information about anaphylaxis observed in the pivotal clinical studies has been described in the Warnings section of the Xolair prescribing information since approval in June 2003," Genentech said in a statement. "As part of our ongoing post-marketing safety surveillance, we have been closely monitoring anaphylaxis and anaphylactoid reactions. Some cases of anaphylaxis reported in this setting were more serious and occurred outside of the two-hour window currently described in the Warnings section of the label." "We will inform health care providers and patients about this new information." Xolair, with which Genentech is partnered with Novartis, generated $102 million in sales in 2006, Novartis Pharmaceuticals CEO Thomas Ebeling said during Novartis' fourth quarter earnings call Jan. 18. "Xolair very often does not get the visibility it deserves at Novartis because Genentech is booking the sales in the U.S., but if you include the Genentech sales, Xolair is already now, after a few years, almost at $500 million in sales," Ebeling said (1 (Also see "Novartis Bullish About Prexige; Anticipates Blockbuster Potential" - Pink Sheet, 18 Jan, 2007.)). Genentech is in the process of acquiring Xolair innovator Tanox. The antitrust waiting period for the $919 million acquisition was extended in January, but is slated to wrap up by the first half of the year (2 (Also see "Genentech’s Tanox Acquisition Delayed Due to FTC Information Request" - Pink Sheet, 29 Jan, 2007.)). - Shirley Haley ([email protected]) |