Roche's Xolair, challenged in asthma, wins 'breakthrough' in food allergies

Peanuts in shell
Xolair could win an FDA approval to treat peanut allergies. (Pixabay/riteshman)

Novartis and Roche’s Xolair has seen a raft of new competitors encroach on its territory over the last few years. But now, it’s ready to carve out a new niche of its own.

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.

Upcoming Webinar

Lifecycle Management Strategies Targeted For Patient Populations with Swallowing Disorders

Hear from industry experts as they discuss life cycle management strategies for patients with swallowing disorders and the overall impact on patient perception. The webinar will include several panel speakers representing different perspectives and case study examples. Save your spot and register today!

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. That green light helped the drug rake in $1.75 billion in the U.S. last year.

Suggested Articles

AbbVie has seen blossoming market share for immunology launches Rinvoq and Skyrizi—and it's eyeing Allergan's neurology biz for a boost, too.

While Novo's Rybelsus launch has slowed due to the pandemic, another version of the med, Ozempic posted strong sales.

AZ sold Atacand and Atacand Plus rights in about 70 countries to Cheplapharm.