New Products

AstraZeneca’s respiratory group scores FDA OK for a blockbuster severe asthma drug

This was the year that analysts had fixed on AstraZeneca’s first hurdle in a combination study for lung cancer as the big catalyst of the year, which would show whether or not CEO Pascal Soriot was on track to finally turn the pharma giant around after five long years at the helm.

Pascal Soriot

AstraZeneca missed that goal, causing considerable fretting about its future. But it didn’t end there. Events have conspired to provide AstraZeneca with a series of H2 wins, capped today with an FDA approval for its asthma drug benralizumab.

The drug will now be sold as Fasenra for eosinophilic asthma, a particularly virulent form of the disease. AstraZeneca $AZN won the approval based on data demonstrating a 51% reduction in exacerbations each year compared to a placebo.

A spokesperson for the company says the drug will come with a $38,000 wholesale cost for the first year — which requires a heavier dosing schedule — and then $28,000 to $33,000 each year after. The step down will place the cost below rivals for severe asthma, adds the spokesman.

Jefferies analysts have pegged peak sales potential at $1.5 billion, and AstraZeneca’s commercial operations will be pressed hard to make that blockbuster projection a reality. Soriot’s own estimate for this drug was $2 billion, a figure he offered when the CEO was pushing hard to persuade investors to reject a takeover attempt by Pfizer.

The drug is designed to latch on to the IL-5α receptor on an eosinophil and beckon natural killer cells to finish them off. It will now go head-to-head against GlaxoSmithKline’s Nucala and Teva’s Cinqair in a very competitive field.

Significantly for AstraZeneca, which has been racking up some big approvals in the oncology arena, this approval marks an advance for one of its respiratory drugs. And Soriot highlighted the fact on a statement:

This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company as we deliver on our pipeline-driven transformation.

AstraZeneca under Soriot has been speedily developing the markets for Lynparza and Tagrisso, with its new checkpoint durvalumab gradually extending its reach into various cancer niches. An early approval for Calquence helped burnish their prospects in the all-important cancer field. But outside of cancer AstraZeneca has struggled, marked by a flop for tralokinumab.



The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 21,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Biomanufacturing