AstraZeneca writes off its second pivotal COPD trial for Fasenra, killing expansion plans

You can write off any upside AstraZeneca’s respiratory drug Fasenra (benralizumab) may have had left on COPD.

The drug, approved last fall for a severe form of asthma, just failed the second of two Phase III studies, providing some definitive proof that it can’t help COPD patients — or offer added relief to AstraZeneca’s $AZN suffering bottom line.

Sean Bohen

The setback will offer added encouragement to GlaxoSmithKline $GSK, which has been aggressively expanding its work with the rival first-in-class drug Nucala, which is now looking to add a COPD approval — even though it only scored mixed results in Phase III. Fasenra also competes with Cinqair from Teva and Xolair from Novartis

AstraZeneca badly needs to build new franchise drugs to grow sales, particularly now that Crestor is getting smashed by generics. Their oncology group has had several key successes on that score — but respiratory and other core focuses have suffered.

The pharma giant hasn’t formally interred its COPD program, but the back-to-back failures in significantly reducing exacerbations leave little doubt about its prospects. CMO Sean Bohen voiced the company’s regret:

“These results are disappointing because uncontrolled COPD patients already on dual or triple inhaled therapy need new treatment options. We will now analyse the complete data sets from the GALATHEA and TERRANOVA trials to further understand these results.”

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Flatiron Health New York City or San Francisco

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