Drug to treat severe food allergies, including nuts, gets FDA approval

Medicine

By Brooke Steinberg

The Food and Drug Administration greenlighted a new drug on Friday that could be life-changing for those with severe food allergies.

Xolair, or omalizumab, was approved to help reduce severe allergic reactions to certain foods in adults and children over the age of 1, including reducing the risk of anaphylaxis that may occur with accidental exposure.

However, the medication is not meant to be used during an allergic reaction — it’s intended to be administered repeatedly every two to four weeks to reduce the risk of future reactions over time.

However, the FDA also noted that patients who take Xolair — which is considered to be the “first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies” — must continue to avoid foods they are allergic to.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, M.D., Ph.D., associate director of the Division of Pulmonology, Allergy and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

There is currently no cure for food allergies, and the only known treatment is strict avoidance of the food and immediate administration of epinephrine in the case of immediate emergency.

The injection, developed by Genentech, has previously been approved to treat some cases of moderate-to-severe persistent allergic asthma, as well as some cases of chronic hives and chronic inflammatory sinus disease with nasal polyps.

A study sponsored by the National Institute of Allergy and Infectious Diseases found that Xolair has helped some people tolerate foods they are allergic to over time.

The study showed that, compared to a placebo, a significantly higher proportion of patients as young as 1 year old with food allergies treated with Xolair were able to withstand small amounts of peanut, milk, egg and cashew without an allergic reaction.

The most common side effects observed in those who took Xolair were reactions at the injection site and fever.

“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,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, said in a statement.

“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.”