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FDA gives breakthrough status to Xolair for food allergies

Food allergies could open up big new market for biologic

Roche and Novartis’ fast-maturing allergy drug Xolair has shown it’s still got plenty more to offer after picking up an FDA breakthrough designation for a new food allergy indication.

The US regulator awarded Xolair (omalizumab) the coveted status for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies, opening up another potential market for a drug that made its debut in the US 15 years ago as an allergic asthma treatment.

Since then Roche and Novartis have built on the drug’s approved uses, expanding its label in allergic asthma and adding a dermatology indication – the treatment of chronic idiopathic urticaria (hives) – in 2014. It’s seen sales grow steadily since launch as a result, with Roche booking sales of around $1.7bn last year and Novartis reporting another $920m.

Food allergies could open up a new and sizeable market for the immunoglobulin E (IgE) inhibitor. It’s estimated that food allergies cause around 200,000 hospital visits each year in the US alone, and that up to 8% of children and 4% of adults are affected by them.

Sandra Horning

Sandra Horning

“Food allergies can have a significant impact on the lives of children and adults, and they are a growing public health concern for which there are currently no FDA-approved treatments,” said Roche’s chief medical officer Sandra Horning.

“We are committed to helping address this high unmet medical need and look forward to working with leaders in the field to further develop Xolair as a potential medicine to help people with this condition that can be life-threatening,” she added.

Roche and Novartis say they are working with the National Institute of Allergy and Infectious Diseases (NIAID) on the design of a pivotal trial for Xolair in food allergy prevention, but aren’t disclosing details just yet.

There are a number of published studies looking at the use of Xolair in the food allergy setting. Last year, a National Institutes of Health (NIH) team showed in a pilot study that adding the drug to oral immunotherapy (OIT) regimens used to induce tolerance to food allergens improved their efficacy.

After 36 weeks, more than 80% of children who received Xolair and OIT could safely consume two-gram portions of at least two foods to which they were allergic, compared with only a third of children who received placebo and OIT.

Article by
Phil Taylor

13th August 2018

From: Regulatory



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