Roche’s Xolair is first medicine for food allergy in US

Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.

The FDA has cleared the use of the IgE inhibitor to reduce allergic reactions, including life-threatening anaphylaxis, that can occur with accidental exposure to foods in adult and paediatric patients aged one year and older who have one or more IgE-mediated food allergies, which include peanut, milk, egg, wheat, cashew, hazelnut, and walnut.

Interim analysis results from the phase 3 OUtMATCH study showed that Xolair (omalizumab) significantly increased the amount of peanut, milk, egg, and cashew that it took to cause an allergic reaction.

For example, results showed 68% of patients treated with Xolair doses every two to four weeks over a 16- to 20-week follow-up period tolerated at least 600 mg of peanut protein – equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter – without moderate to severe allergic symptoms, compared to 5% of those treated with placebo.

Approximately 3.4 million children and 13.6 million adults in the US have been diagnosed with IgE-mediated food allergies, based on estimates for 2024, said Roche, and food-related anaphylaxis is thought to be responsible for around 30,000 emergency room visits each year.

The prevalence of food allergies has also been on the rise for the past 20 years, for reasons that are not wholly clear, but could include pollution, dietary changes, and less exposure to microbes during early childhood.

“The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches, and holiday dinners with friends and family,” said Kenneth Mendez, president and chief executive of the Asthma and Allergy Foundation of America (AAFA).

“Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies.”

Xolair has been around since the early 2000s as a treatment for severe allergic asthma, but found a new lease of life in 2014 when it was approved for refractory chronic spontaneous urticaria (CSU), which pushed sales above the $1 billion-a-year threshold.

Since then, a green light for nasal polyps and a new self-injector formulation helped US sales reach almost $2.5 billion last year out of global sales of approximately $3.8 billion.

The Xolair substance patent has already expired and formulation patents are due to expire in the next month in Europe, and in November 2025 in the US. Several companies have biosimilars in late-stage development, including Teva, Celltrion, Aurobindo, Kashiv Biosciences, and Glenmark.