AstraZeneca has reported negative results from the GALATHEA trial after the study failed to meet its primary endpoint.

However, the safety and tolerability data reported in GALATHEA were consistent with those observed in previous trials of Fasenra (benralizumab).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

GALATHEA was a Phase III trial designed to evaluate the safety and efficacy of Fasenra to treat patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The randomised, double-blind, 56-week placebo-controlled, multi-centre trial enrolled 1,656 COPD patients with a history of exacerbations.

The trial’s primary endpoint was a statistically significant reduction of exacerbations in COPD patients.

“We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.”

Its secondary endpoints included evaluation of the effect of Fasenra on health status/health-related quality of life, analyse the effect of benralizumab on pulmonary function, among others.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

AstraZeneca global medicines development executive vice-president and 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.”

Fasenra is a monoclonal antibody that employs natural killer cells to induce rapid and near-complete depletion of eosinophils, a type of white blood cell that is a normal part of the body’s immune system. The drug has been developed by AstraZeneca’s biologics research and development arm, MedImmune.

Fasenra is currently approved as an add-on treatment for severe eosinophilic asthma in the US, the EU, Japan, and other countries.