Roche, Novartis move Xolair closer to FDA finish line for food allergies

On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes.

On Tuesday, Roche revealed that the FDA has accepted its supplemental biologics license application (sBLA) on a priority review basis for Xolair to reduce accidental allergic food reactions, including anaphylaxis, in adults and children ages 1 year and older.

With an approval, Xolair would become the first treatment on the market to reduce allergic reactions to multiple foods due to accidental exposure. Roche expects a decision from the FDA during the first quarter of 2024.

After injections of Xolair every two to four weeks—with intervals determined by body weight and serum immunoglobulin E (IgE) level—patients would be protected from accidental exposure to foods to which they are allergic. The treatment is not designed to allow patients to freely eat the foods.

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a release.

Backing the submission are results of a phase 3 trial which was co-sponsored by the U.S. National Institutes of Health. The OUtMATCH study showed that Xolair can significantly increase the amount of peanut (primary endpoint) and milk, egg and cashew (secondary endpoints) it took to cause an allergic reaction compared to placebo.  

In the U.S., 17 million people have food allergies, with more than 40% of children and more than half of adults having experienced at least one severe reaction. Food-related anaphylaxis causes roughly 30,000 emergency room visits annually in the U.S.

Xolair works by inhibiting IgE antibodies, which cause chemical reactions that produce inflammation seen in allergy and asthma attacks. In 2018, the FDA granted breakthrough designation for Xolair as a treatment for food allergies.

Xolair generated $4 billion in worldwide sales last year, including $2.8 billion in the U.S. Novartis and Roche’s subsidiary Genentech commercialize Xolair in the U.S., with Novartis handling the rest of the world.

Three months ago, Nestle sold its peanut allergy drug Palforzia to Stallergenes Greer for an undisclosed sum. In 2020, Palforzia was the first peanut allergy drug approved by the FDA but its sales never indicated it could reach Evaluate Pharma’s projection of $1.28 billion by 2024. Nestle acquired Palforzia in a $2.1 billion buyout of Aimmune Therapeutics.