AstraZeneca and Amgen’s Tezspire met the main goals of a late-stage trial in another inflammatory disease, a win that could open the door to a potentially lucrative label expansion.
The two companies said Thursday their drug, which is already approved for severe asthma and chronic rhinosinusitis, met all of its objectives in a Phase 3 study in eosinophilic esophagitis. They didn’t provide details, but said that treatment was associated with “statistically significant and clinically meaningful improvements” across all main and secondary study goals. Those effects — on markers as well as symptoms of disease activity and severity — were evaluated at 24 weeks and sustained over the course of a year, AstraZeneneca and Amgen said.
The partners will share the results with regulatory authorities and present them at an upcoming medical meeting, the companies said.
Tezspire is a monoclonal antibody that binds to and blocks the activity of the protein TSLP, which is implicated in certain inflammatory conditions such as asthma. It’s already become an important product for both companies. Amgen and AstraZeneca last year each reported more than $1 billion in Tezspire sales. And AstraZeneca recorded $390 million in the second quarter alone, a 45% jump compared to the same period last year. (Amgen holds U.S. rights to Tezspire, with AstraZeneca owning the rest.)
An expanded approval in eosinophilic esophagitis, or EoE, could drive sales even higher. The condition is characterized by the buildup of white blood cells called eosinophils in the lining of the esophagus, leading to difficulty with swallowing. Patients often receive drugs known as proton pump inhibitors or swallowed topical corticosteroids, but around half of them don’t respond to initial treatments, AstraZeneca said in a statement.
More than 470,000 people in the U.S. are affected by EoE, and the disease is increasing in prevalence, wrote William Blair analyst Matt Phipps. Those factors “support an attractive third indication for Tezspire with blockbuster potential,” he added in a Wednesday client note.
Should Tezspire win a clearance in EoE, it would compete directly against Sanofi and Regeneron’s Dupixent, an anti-inflammatory medicine approved for several conditions. Regeneron and Sanofi have also described EoE as a “meaningful growth driver” with big sales potential, Phipps wrote.
Tezspire’s success could help AstraZeneca reach its stated goal of generating $80 billion in annual sales by 2030. It’s an important medicine for Amgen, too, which is relying on products like Uplizna, Imdelltra and Repatha to support growth ahead of crucial obesity drug readouts next year.
