Blow for AZ as late stage COPD trial fails

AstraZeneca Amenities Building - Mississauga - Sept 2005
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AstraZeneca’s respiratory drug Fasenra has failed in chronic obstructive pulmonary disease (COPD),  in a market hotly contested by its UK rival GlaxoSmithKline.

Fasenra (benralizumab), developed by AZ’s biologics unit MedImmune, is from a class of drugs known as IL-5 inhibitors which are just beginning to get to market in respiratory diseases.

AZ’s drug was FDA approved in November for severe eosinophilic asthma, almost two years after GSK’s rival Nucala (mepolizumab) got the green light in the same indication.

Since then GSK has got Nucala approved in the autoimmune disease eosinophilic granulomatosis, and is awaiting the outcome of an FDA review in COPD, with a decision due later this year.

So getting Fasenra on the market in COPD will be important to AZ as it bids to take market share from GSK.

AZ also needs to generate more revenues as generic competition begins to eat into sales of its older drugs.

So the news that Fasenra failed in a trial in COPD is a blow for AZ – although GSK’s drug is by no means a shoo-in for approval in COPD after some mixed phase 3 results.

AZ’s GALATHEA phase 3 trial is a randomised, double-blinded, 56-week placebo-controlled multi-centre trial assessing safety and efficacy of Fasenra, as an add-on to dual or triple inhaled therapy compared with placebo.

The patient group involved had moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.

But it failed to meet the primary endpoint of a statistically significant reduction of exacerbations in patients COPD.

There were no new safety signals, and AZ is awaiting the outcome of the TERRANOVA trial, due later this quarter, before making a decision on what to do with Fasenra in COPD.

[caption id="attachment_28515" align="alignnone" width="160"] Sean Bohen[/caption]

AZ’s chief medical officer, Dr Sean Bohen, said: “COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.”