The U.S. Food and Drug Administration has approved Xolair as the first and only medicine for people with one or more food allergies after the clinical trial data for the injectable asthma medication showed it helped people curb food-related allergic reactions.
“The FDA approval is based on positive data from the Phase III OUtMATCH study,” Genentech announced on Friday.
The study showed “a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo.”
“The FDA approval of Xolair for food allergies is meaningful to me on a personal level, not only as a physician, but as a patient and a parent of a child with food allergies, too,” Dr. Larry Tsai, VP and global head of respiratory, allergy and infectious disease product development at Genentech told ABC News. “For the first time, people with one or more food allergies have a treatment option with Xolair that can help reduce allergic reactions that may occur with an accidental exposure.”
Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development, added in a press release that “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.”
What to know about Xolair medication for people with food allergies
The studies first showed promising results in late December, experts at the time said they were hopeful that the injection would eventually win FDA approval as an allergy treatment for children.
Pharmaceutical developers Genentech and Novartis first announced in December 2023 that the FDA was prioritizing the review of its application for use of Omalizumab, an allergy-induced asthma medicine, in cases of accidental exposure to foods like peanuts, eggs or milk.
The small study, which needs more research before a potential FDA approval, combined with prior research points to how alternate use of the medication marketed as Xolair could potentially help to prevent allergic reactions in people who have multiple food allergies, especially anaphylaxis.
The federally funded trial backed by the National Institute of Allergy and Infectious Diseases is set to finish in 2026.