This morning Genentech announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Xolair to treat exposure to those deadly food allergies.
There are approximately 15 million people in the United States with a food allergy and that number continues to grow. This morning Genentech announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Xolair to treat exposure to those deadly food allergies.
South San Francisco-based Genentech said the designation will allow the regulatory agency to an expedited potential review of the medicine as a treatment for exposure to food allergens. Genentech said this is the 23rd such designation its portfolio of medicines has received from the FDA.
Sandra Horning, Genentech’s chief medical officer, called food allergies a growing public health concern in the United States. Horning said there are currently no FDA-approved treatments for food allergies and noted that Genentech is “committed to helping address this high unmet medical need.”
Genentech noted that food allergies result in an estimated 200,000 emergency room visits each year. Approximately 8 percent of children and 4 percent of adults in the U.S. are affected by food allergies, the company said.
The FDA awarded Xolair (omalizumab) the designation based on data from multiple studies that showed Xolair was a safe and effective treatment for a range of food allergens, including peanuts, milk, effs and more. The clinical studies examined Xolair as both a monotherapy and in combination with oral immunotherapies, Genentech said. In December a combination of Xolair and oral immunotherapies showed remarkable efficacy in a Phase II trial. More than 80 percent of children who received the combination treatment were able to safely consume two-gram portions of at least two foods to which they were allergic, compared with only a third of children who received placebo and OIT, the National Institutes of Health announced. Omalizumab blocks the activity of IgE, an immune system molecule central to the allergic response.
Xolair has already been approved by the FDA as a treatment for moderate to severe asthma in patients ages six and older. It has also been approved as a treatment for chronic idiopathic urticaria in patients 12 years and older.
The studies, Genentech added, were supported by independent sponsors including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Genentech said it, as well as Novartis, are working with NIAID and the Consortium of Food Allergy Research (CoFAR) to initiate a potentially pivotal study evaluating the efficacy and safety of Xolair in multiple food allergies. Details will be provided at a later date.
