It hasn’t been an easy summer for AstraZeneca in the respiratory department, but the British drugmaker has finally come up with a win.
On Friday, the FDA bestowed its breakthrough therapy designation on candidate tezepelumab, a severe asthma drug that treats a broader population than AZ’s Fasenra does and could help boost the company in its respiratory market-share battle with GlaxoSmithKline.
The agency’s move will help speed the prospect down the regulatory pathway, meaning tezepelumab could snag a first-in-class go-ahead sooner rather than later. The drug has the potential to become the first in its class of medicines that block thymic stromal lymphopoietin (TSLP), a protein linked to multiple inflammatory diseases.
If it can, it’ll help AstraZeneca break out of the severe eosinophilic asthma population—where its Fasenra is currently facing down Nucala from GlaxoSmithKline and Cinqair from Teva—and into the wider severe asthma arena, which AZ says affects up to 33.4 million people worldwide.
“Tezepelumab is exciting because it has the potential to treat a broad population of severe asthma patients, including those ineligible for currently-approved biologic therapies,” AstraZeneca R&D chief Sean Bohen said in a statement.
In the broader severe asthma field, AZ will take on Novartis’ Xolair, which was treating moderate to severe allergic asthma before Nucala, the first severe eosinophilic asthma drug to hit the market, came around to threaten its share. Novartis and partner Roche, though, are working to further diversify Xolair to ease the sting of competition, last month winning an FDA breakthrough of their own in food allergies.
The tezepelumab speedup marks a bright spot for AstraZeneca in what’s been a tough few months for its respiratory portfolio, particularly in its GSK rivalry. The bad news began rolling in in May, when AstraZeneca said Fasenra had flopped not one but two trials in COPD, scuttling its chances of scoring an indication in a disease area where Glaxo had already posted positive results. Then, England’s cost watchdogs said they’d only recommend Fasnera in patients who can’t use Nucala, among other conditions.
More recently, it was COPD drug Bevespi that handed GSK a win, coming up short against Glaxo’s Anoro in a head-to-head trial.
With tezepelumab in severe asthma, though, AZ should have some breathing room. GSK’s most advanced severe asthma candidate is still in phase 1, and Thursday it said it would reduce its asthma sales force as part of a pivot “to focus on COPD, where we feel we have the biggest opportunity for growth.”