Amgen, AstraZeneca bolster their case for breakthrough asthma program as FDA considers taking up a review
Just a few days after submitting a BLA for their highly-touted asthma program, Amgen and AstraZeneca released new data they hope will continue to strengthen their FDA pitch.
The companies released further detailed Phase III results for tezepelumab early Thursday morning, and published the full dataset in the New England Journal of Medicine. Tezepelumab plus standard of care “demonstrated superiority” across the primary and all key secondary endpoints compared to the standard of care alone, they said.
As part of the new results, Amgen and AstraZeneca highlighted new pre-specified, exploratory analyses regarding reductions in annualized asthma exacerbation rates. Researchers observed patients from four subgroups over 52 weeks, dividing them up based on blood eosinophil count and fractional exhaled nitric oxide levels.
Among those with elevated blood eosinophil counts and FeNO levels, tezepelumab reduced AAERs by 77% compared to the control — a figure Amgen and AstraZeneca said was clinically meaningful. Another measure showed the experimental drug reduced the rate of exacerbations requiring hospitalization by 85% over 52 weeks.
The data build upon the results released by the pair in February, where they said tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared to the control arm. Tezepelumab is a monoclonal antibody given once monthly and already sports the FDA’s breakthrough therapy designation.
Amgen and AstraZeneca have been drumming up excitement over this program for years, particularly since earning that BTD back in late summer 2018. Back then, AstraZeneca exec Bahija Jallal called the results “unprecedented” and analysts pegged peak sales around $4.5 billion.
When topline Phase III results for tezepelumab came out last November, the pair again played up their excitement — David Reese, Amgen’s head of R&D, said he was “absolutely thrilled” with the study, while Mene Pangalos called the data “exciting.”
Some concern arose last December, however, regarding a key differentiator from drugs like Dupixent. That month, tezepelumab failed in a Phase III trial on severe asthma patients in reducing the number of oral corticosteroids patients took to control their asthma. Amgen called the results “surprising,” pointing out trial design flaws as a possible culprit.
In an interview with Endpoints News on Wednesday, AstraZeneca’s senior VP of US respiratory and immunology Mina Makar said the partners were looking at future clinical studies to re-address that failed corticosteroids endpoint but noted that very few US asthma patients are actually on chronic steroids. Meanwhile, in his telling, clinicians are far more concerned about getting the 80% of severe asthma patients who are ineligible for existing biologics onto therapy — an area the drugmakers think they can make a serious dent, even with Dupixent on the market.
But analysts have proved skeptical, with Baird’s Brian Skorney noting in December that physicians may ultimately prefer Dupixent over tezepelumab, should it be approved. Nonetheless, the Amgen/AstraZeneca program could still see peak sales as high as $2.5 billion.