Novartis and Roche tee up self-injected Xolair option with FDA filing for prefilled syringe

Roche Genentech
Novartis and Roche co-promote asthma med Xolair in the U.S., and, with a recent FDA filing, hope to provide patients with a self-administration option outside the clinic. (Roche)

Novartis and Roche have struggled to keep their aging asthma blockbuster Xolair relevant, especially as competition from rival drugs—like Sanofi and Regeneron's blockbuster Dupixent—mop up sales.

But now, the drugmakers are advancing a prefilled syringe version that would allow patients and caregivers to inject the drug themselves, padding the case for Xolair's convenience in the pandemic era. The self-administration option is under review at the FDA, with a decision due early next year.

The coronavirus's spread makes at-home dosing more important than ever, Roche's Genentech unit said in a release.

“Due to the COVID-19 pandemic, there is an urgent need to provide self-administration of Xolair to our patients, particularly those who are considered high-risk for severe illness," Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech, said.

Since its first approval (PDF) in 2003 for allergic asthma, roughly 460,000 U.S. patients have been treated with Xolair, Genentech said. The drug boasts a green light in moderate to severe persistent asthma in patients 6 years and older whose symptoms can't be controlled with inhaled steroids. The drug also has a nod to treat chronic hives in patients 12 years and up.

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The drug is currently available in lyophilized, sterile powder form and in a prefilled syringe designed for hospital use. If the new prefilled syringe wins approval, patients will still need to begin Xolair therapy under doctor supervision. That's partly because Xolair carries a risk of anaphylaxis, a severe allergic reaction that can be fatal. Anaphylaxis can occur right after the drug is injected for the first time or after many injections, and it can also crop up days after Xolair is administered. 

To curb those risks, patients and caregivers will need training from their healthcare providers on proper subcutaneous injection technique and on recognizing early signs of anaphylaxis, Genentech said. 

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Novartis and Roche have worked to expand Xolair's reach with new formulations and approvals in new diseases. In 2014, the drug won the FDA's blessing to treat chronic hives—specifically, chronic idiopathic urticaria, or hives with no known cause.

Then, in October 2018, the FDA green lit the prefilled syringe designed for use in the hospital. Its extended shelf life and ready-to-use formulation were designed to make Xolair more convenient, not only than its previous formula but rival drugs, too. 

And in August of that year, the partners snared an FDA breakthrough designation for Xolair as a treatment for food allergies, hoping to boost the drug's label amid an onslaught of asthma competition from AstraZeneca's Fasenra, GlaxoSmithKline's Nucala and Teva's Cinqair.

With the new self-administration option, Xolair could compete with Sanofi and Regeneron's eczema med Dupixent on convenience. First approved for atopic dermatitis, Dupixent won approval as an add-on maintenance treatment for asthma in 2018, positioning it as the only asthma biologic that patients could administer at home. That nod inspired Leerink analyst Geoffrey Porges to predict $2.5 billion in peak Dupixent asthma sales.

In the meantime, Novartis has already touted the success of its prefilled Xolair syringes in Europe, where the formulation snared approval for home use in 2018. Last year, Xolair pulled in (PDF) €1.17 billion ($1.2 billion) outside the U.S., a 13% increase year over year—with those gains partly credited to the at-home dosing option's rollout in Europe.