FDA Advisory Committee Unanimously Recommends Approval of Xolair
Thursday May 15, 6:29 pm ET
Potential First Biologic Treatment for Allergic Asthma Targets Underlying Cause of Disease
GAITHERSBURG, Md.--(BUSINESS WIRE)--May 15, 2003--Genentech, Inc. (NYSE: DNA - News), Novartis Pharmaceuticals Corporation, an affiliate of Novartis AG (NYSE: NVS - News) and Tanox, Inc. (Nasdaq: TNOX - News) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted unanimously that Xolair(TM) (omalizumab) for Injection be approved based on a favorable risk-benefit profile for the treatment of moderate-to-severe allergic asthma in adults and adolescents. Xolair represents a novel treatment approach as the first humanized monoclonal antibody developed for the treatment of allergic asthma, and the only allergic asthma treatment designed to block the IgE antibody, specifically targeting an underlying cause of allergic asthma. Based on the results of today's advisory committee meeting, the sponsors will conduct further discussions with the FDA regarding product labeling and post-marketing commitments.
In clinical trials of moderate-to-severe patients, Xolair was found to reduce asthma exacerbations (allergic asthma attacks) and enable many patients to reduce or eliminate usage of inhaled corticosteroids. The companies are seeking approval to market Xolair in the United States as a potential maintenance therapy for the prophylaxis of asthma exacerbations and control of asthma symptoms in adults and adolescents (12 years and older) with moderate-to-severe allergic asthma that is inadequately controlled despite the use of inhaled corticosteroids.
"Today's decision is an important milestone for allergic asthma sufferers who cannot manage their condition with the treatments currently available," said Hal Barron, M.D., FACC, vice president, Medical Affairs for Genentech. "If approved, Xolair would be the first biologic therapy for patients with allergic asthma, and the only therapy that specifically targets IgE, an underlying cause of the condition."
Cynthia Hogan, vice president, Respiratory and Dermatology Therapeutic Franchise for Novartis Pharmaceuticals Corporation added, "We are very pleased with the positive feedback provided by the advisory committee members today. We believe that Xolair can provide benefit to an important population of allergic asthma sufferers, and we look forward to working with the FDA to make Xolair available to patients."
"After many years of development for Xolair, we are delighted with the FDA committee recommendation and the potential of helping the many allergic asthma patients," said Nancy T. Chang, president and chief executive officer for Tanox, Inc.
Xolair is being jointly developed under agreements among Novartis Pharma AG, Genentech, Inc. and Tanox, Inc. The Biologics License Application for Xolair was filed in June 2000 and a supplemental data amendment was filed in December 2002. The FDA generally follows the advice of its advisory committees, although it is not bound by these recommendations. A decision by the FDA is expected in late June 2003.
If approved by the FDA, Xolair would be the first IgE blocker and the first biologic therapy for the treatment of moderate-to-severe allergic asthma. Furthermore, it is potentially the first asthma product to be administered every two or four weeks. Xolair is designed specifically to block the IgE antibody, a key underlying cause of allergic asthma. When an allergen (e.g., dust, mold, pollen) interacts with (cross-links) IgE bound to mast cells in the human immune system, these cells release inflammatory chemicals such as histamine and leukotrienes that lead to the inflammation and bronchial constriction of allergic asthma. Decreasing the amount of IgE bound to mast cells can disrupt the release of these chemical mediators that cause the clinical symptoms of allergic asthma.
Xolair Clinical Trial Results
The advisory committee's discussions focused on data from two 52-week pivotal Phase III clinical trials with 1,071 allergic asthma patients, as well as data from several supportive safety and efficacy studies. The pivotal trials were designed to investigate a dual benefit of reduction in asthma exacerbations and reduction in the dosage of inhaled corticosteroids. Patients treated with Xolair showed significant improvements in asthma exacerbations and symptoms, and most patients reduced their use of steroids and rescue bronchodilators.
In clinical trials when used as an add-on therapy to inhaled corticosteroids, Xolair was found to reduce exacerbations by approximately 50 percent. Additionally, the average dose of inhaled corticosteroids in patients taking Xolair in the two pivotal trials was reduced by 83 percent and 75 percent respectively, compared to 50 percent in the placebo groups. Steroid use was discontinued in 40-43 percent of patients in the Xolair groups compared to 19 percent in the placebo groups.
The expanded safety database submitted to the FDA includes clinical data from more than 6,000 patients, of which approximately 4,200 patients have been treated with Xolair. In clinical trials, Xolair treatment was generally well tolerated and the frequency of reported adverse events was comparable between the Xolair-treated and control groups. The most frequently observed adverse events included viral infections, sinusitis, upper respiratory infection and headache. Serious adverse events were infrequent and of similar incidence in both the Xolair and control groups. The final efficacy and safety description in the product labeling will be determined by the FDA.
About Allergic Asthma
Allergic asthma is a chronic inflammatory disorder of the airways in which exposure to an allergen (e.g., dust, mold, pollen) triggers an allergic cascade, resulting in airway inflammation and obstruction. Asthma results in more than two million emergency room visits and more than 5,000 deaths in the United States each year, according to the Center for Disease Control and Prevention's National Center for Health Statistics. |
