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.


Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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

With AbbVie's two most recent launches outperforming expectations, investors could be looking at a steal with an Allergan merger looming.

Investors are clamoring for a CVR created in the BMS-Celgene deal, but it will only pay off if the FDA approves three hot pipeline projects.

Muzammil Mansuri, Sanofi’s EVP of strategy and business development since February 2016, is retiring at the end of November.