Roche/Novartis’ Xolair has been awarded breakthrough status in the US for treatment of severe allergic reactions after accidental exposure to foods allergens.
Xolair (omalizumab), a monoclonal antibody targeting Immunoglobulin E, is already approved in the US to treat asthma and chronic idiopathic urticaria (chronic hives without a known cause).
Breakthrough Therapy Designation for food allergies - which affect up to 8 percent of children and 4 percent of adults in the US - comes on the back of data from seven clinical studies that assessed the efficacy and safety of the drug against a range of food allergens including peanut, milk, egg and others.
“Food allergies can have a significant impact on the lives of children and adults, and they are a growing public health concern for which there are currently no FDA-approved treatments,” said Sandra Horning, chief medical officer and head of Global Product Development.
“We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening.”