As tezepelumab awaits FDA decision, Amgen and AstraZeneca tout more data from the Phase III study
As AstraZeneca and Amgen’s Dupixent challenger awaits a decision by the FDA, the companies are touting new data they hope could bolster their case.
Researchers revealed additional results from a pivotal Phase III trial for AstraZeneca and Amgen’s tezepelumab over the weekend, studying the treatment in severe, uncontrolled asthma. In an exploratory analysis looking at patients with or without reported nasal polyps, tezepelumab showed it can reduce asthma exacerbation by 86% in the former group and 52% in the latter when compared to standard of care.
“These results further strengthen our confidence in tezepelumab’s potential to address a significant unmet need across a broad population of patients with severe asthma, including those with comorbid nasal polyps,” Amgen R&D chief David Reese said in a statement.
The data come two months after tezepelumab scored priority review from regulators, with a decision expected in the first quarter of next year.
Peak sales for the drug have been estimated at $2.5 billion, with some early estimates from 2018 going as high as $4.5 billion. While the larger figure now appears untenable with the atopic dermatitis indication having been scuttled, and the smaller estimate doesn’t reach as high as the blockbuster from Regeneron and Sanofi — Dupixent raked in nearly $4 billion last year — tezepelumab could still carve out a hefty slice of the market.
Saturday’s results come from a Phase III study published in full back in May, in which tezepelumab plus standard of care “demonstrated superiority” across the primary and all key secondary endpoints compared to the standard of care alone. When topline results came the previous November, Reese played up the readout despite limited public data, declaring he was “absolutely thrilled” with the study.
The companies filled everyone in on the actual topline data in February of this year, saying tezepelumab cut the rate of severe asthma attacks by 56% at the one-year mark compared with standard of care alone.
Not everything has been smooth sailing for the drug, however, given monthly as a subcutaneous injection. After flunking two Phase II trials in AD, AstraZeneca revealed the pair had thrown in the towel on the condition in their second quarter update earlier this summer.
Additionally, tezepelumab whiffed on another area Dupixent managed to lock down in asthma — reducing the number of oral corticosteroids asthma patients needed to take. Amgen and AstraZeneca’s treatment failed to hit that mark in another Phase III study, a result Reese called “surprising” in December 2020.
Correction: This article has been corrected to amend tezepelumab’s method of delivery. It is given via subcutaneous injection, not intravenous infusion.