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.

Cambrex Webinar

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

Wednesday, May 27, 2020 | 10am ET / 7am PT

A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.

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

BMS' Opdivo and Yervoy only just won their first approval in previously untreated metastatic NSCLC, but the pair is already making it two.

Wrapping up the legal battle at $10 billion would be a win for Bayer, as it has lost $30 billion in market value since the Monsanto buyout.

Takeda’s Alunbrig has arrived in previously untreated, ALK-positive NSCLC. But there’s plenty of competition waiting to greet it at the door.