FDA grants priority review to omalizumab in treatment of food allergy

Key takeaways:

• Omalizumab increased how much peanut, milk, egg and cashew was needed to cause an allergic reaction.
• If approved, omalizumab would be the first medicine to reduce reactions to multiple foods.

The FDA has accepted a supplemental biologics application for the use of omalizumab to reduce allergic reactions due to accidental exposure in patients aged 1 year and older with at least one food allergy, according to a press release.

The acceptance of this application, which received priority review, was based on positive interim analysis results from the phase 3 OUtMATCH study evaluating omalizumab (Xolair; Genentech, Novartis) among patients allergic to peanut and at least two other common foods.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the press release.

Levi Garraway

Up to 17 million children and adults in the United States have food allergy, according to the release, with prevalence rising over the past 20 years. Also, the company said, more than 40% of children and half of adults with food allergies have experienced at least one severe and potentially life-threatening reaction such as anaphylaxis.

An independent data and safety monitoring board (DSMB) examined the data on the first 165 children and adolescents aged 1 to 17 years who participated in the first stage of the OUtMATCH study, sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), in a preplanned interim analysis.

Compared with placebo, the DSMB found that omalizumab significantly increased the amount of peanut, milk, egg and cashew required to cause an allergic reaction in these patients. Also, safety findings were consistent with omalizumab’s known benefit-risk profile across its approved indications and in previous clinical trials.

The DSMB recommended halting enrollment into the first stage of the trial based on these results, and NIAID accepted the recommendation.

If approved, omalizumab would be the first medicine that reduces allergic reactions to multiple foods after accidental exposure, according to the release. However, the company cautioned, patients with these allergies would still need to avoid the foods that they are allergic to when taking omalizumab.

Genentech expects the FDA to make a decision in the first quarter of 2024.

Reference:

• Antibody reduces allergic reactions to multiple foods in NIH trial. https://www.nih.gov/news-events/news-releases/antibody-reduces-allergic-reactions-multiple-foods-nih-trial. Published Dec. 19, 2023. Accessed Dec. 19, 2023.