FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

People with food allergies finally have a medicine that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades.

The FDA has blessed Roche and Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. The drug is approved for people ages 1 year and older with certain allergies.

The therapy is for people with IgE-mediated food allergies, a classification that includes 160 foods, the most common of which are peanuts, milk, eggs, wheat, soy and tree nuts.

Xolair is not designed to allow patients to freely eat these foods. It just helps them avoid severe reactions, including anaphylaxis, a life-threatening condition that can happen immediately as the immune system releases chemicals that can cause the body to go into shock.

There are 3.4 million children in U.S. that have food allergies and more than 40% of them have had at least one severe reaction, according to Roche subsidiary Genentech. Food reactions cause approximately 30,000 emergency room visits each year in the U.S.

The approval came just two months after the FDA accepted the companies’ supplemental biologics license application in this indication.

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.

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

Study results showed 68% of patients treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo. This amount is equivalent to approximately two and a half peanuts, or half a teaspoon of regular peanut butter.

Xolair was first approved by the FDA in 2003 for asthma. The drug generated $3.9 billion in sales last year. 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.

“Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction,” Reshema Kemps-Polanco, Novartis U.S. chief commercial officer, said in a release. “Today’s approval of Xolair represents a paradigm shift in the way food allergies can be managed.”

In September of last year, 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.