The drug has nabbed the FDA’s breakthrough designation as a treatment for food allergies, setting it up for a quick trip to the regulatory finish line. The new FDA tag comes on the back of data generated through seven clinical trials over the past decade that evaluated Xolair against common food allergens, including peanuts, milk and eggs.
Food allergies, which can be life-threatening, affect up to 8% of children and 4% of adults in the U.S., Roche’s Genentech said—and their incidence is increasing. And right now, they have no FDA-approved treatments, Roche chief medical officer Sandra Horning pointed out in a statement.
Xolair, which started out as a treatment for allergic asthma, has seen a trio of new rivals step into that arena in recent years. GlaxoSmithKline’s Nucala, Teva’s Cinqair and AstraZeneca’s Fasenra have all won approval to treat severe eosinophilic asthma, poaching some patients that had previously turned to Xolair in the absence of a drug for their specific asthma type.
As of now, though, while those drugmakers are working to snag additional indications for their medications, none of them is working on food allergies.
That’s not to say others aren’t, however. Sanofi, for one, is testing its new Regeneron-partnered atopic dermatitis drug Dupixent as a treatment for peanut allergies.
Xolair’s most-recent FDA nod was for chronic idiopathic urticaria, also known as chronic hives.