AstraZeneca and its global biologics research and development arm MedImmune have received approval from the European Commission (EC) for their Fasenra (benralizumab) for the treatment of severe eosinophilic asthma in adult patients.

The monoclonal antibody has been indicated as an add-on maintenance treatment in adults whose asthma is inadequately controlled with high-dose inhaled corticosteroids and long-acting beta-agonists.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Fasenra triggers natural killer cells to stimulate direct, fast and near-complete depletion of eosinophils.

AstraZeneca Global Medicines Development executive vice-president Sean Bohen said: “Fasenra is our first respiratory biologic medicine.

“Today’s decision from the EC follows the recent approval of Fasenra in the US, and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation.”

“The EC approval is based on data from the WINDWARD programme that included six Phase III trials, SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE.”

The EC approval is based on data from the WINDWARD programme that included six Phase III trials, SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE.

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.

Performed in a total of 2,510 subjects aged 12 and above, the randomised, double-blinded, parallel-group, placebo-controlled SIROCCO and CALIMA trials assessed the safety and efficacy of a 30mg dose of subcutaneous benralizumab over 56 weeks.

Results from these trials demonstrated a significant decrease in asthma exacerbations, along with improved lung function and asthma symptoms, when compared to placebo.

During the registrational trial ZONDA, patients administered with benralizumab are reported to have experienced statistically significant and clinically meaningful decrease in daily-maintenance, OCS use.

Fasenra is currently being further studied in the Phase III VOYAGER programme for severe chronic obstructive pulmonary disease (COPD).