US FDA approves Xolair as first and only medicine for children and adults with one or more food allergies

FDA approves Xolair as first and only medicine for children and adults with one or more food allergies

Roche announced that the US Food and Drug Administration (FDA) has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterised by the rapid onset of symptoms following exposure to certain food allergens. Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is widely available and can now be prescribed for appropriate patients with IgE-mediated food allergy in the US.

“Xolair offers patients and families an important new treatment option that can help redefine the way food allergies are managed and reduce the often-serious allergic reactions that can result from exposure to food allergens,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development. “Today’s approval builds on 20 years of patient experience and an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”

“The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches, and holiday dinners with friends and family,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America (AAFA). “Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”