Amgen, AstraZeneca score FDA nod for blockbuster hopeful asthma drug Tezspire

With an ahead-of-schedule FDA approval for their asthma treatment Tezspire, Amgen and AstraZeneca have a chance to cut into the dominance of Regeneron and Sanofi’s Dupixent.

Tezspire is an add-on maintenance treatment for those 12 and older with severe asthma. The monoclonal antibody is the only biologic shown to significantly reduce exacerbations across a broad spectrum of severe asthma patients, who make up roughly 10% of the world’s 339 million asthma sufferers, the companies say.

The drug sets itself apart as a treatment by targeting the thymic stromal lymphopoietin, a cytokine which can cause body to go into overdrive.

“By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options,” David Reese, M.D., Amgen’s R&D chief, said in a statement.

While Tezspire has blockbuster potential, Jefferies analysts cautioned investors to be patient as "launches do not work well" in the omicron environment. One big plus for Tezspire as opposed to Dupixent is its label, Jefferies analysts wrote to clients. While Dupixent’s label says that the drug does not show benefit in patients with low levels of eosinophil, there is no such qualifier for Tezspire.

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For their part, Piper Sandler analysts see the drug crossing the blockbuster threshold later this decade.

Since it will "take time to get reimbursement coverage in place," Piper Sandler sees Tezspire generating $50 million in revenue in 2022. They expect sales to grow quickly to $500 million in 2023, $835 million in 2024 and $1.12 billion in 2025.

"With no pre-existing asthma biologic treatment in place for low-eosinophilic patients, and with impressive benefit demonstrated in this patient population, we like the potential for commercial success," Piper Sandler analysts wrote in a note to clients. 

Tezspire scored an FDA priority review based on results from the phase 2 Pathfinder and phase 3 Navigator trials. The studies showed superiority over placebo across every primary and secondary endpoint in patients with severe asthma.

It hasn’t been all smooth sailing for Tezspire. The Source phase 3 trial, designed to show that injections of the drug every four weeks could reduce the need for oral corticosteroids without loss of asthma control, came up short.

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Tonya Winders, the CEO of the Allergy & Asthma Network, called the approval “long-awaited positive news for the asthma community.

“For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation,” Winders said in a statement.