FDA approves first new med for children and adults with one or more food allergies

The US Food and Drug Administration (FDA) has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged one year and older with IgE-mediated food allergy, Swiss pharm giant Roche (ROG: SIX) announced on Friday.

This marks the fourth FDA-approved indication for Xolair across allergic and inflammatory conditions, including moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).

Since its initial approval in 2003, for the treatment of moderate to severe persistent allergic asthma in certain patients, more than 700,000 patients have been treated with Xolair in the USA. Full-year 2023 global sales of the drug were 2.18 billion Swiss francs ($2.5 billion).