The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for AstraZeneca’s Fasenra (benralizumab) to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that can cause damage to multiple organs and tissues.

Fasenra is AstraZeneca’s first respiratory biologic. The treatment was developed with the company’s global biologics research and development arm MedImmune and is in-licensed from BioWa.

AstraZeneca chief medical officer and global medicines development executive vice-president Sean Bohen said: “EGPA is a rare, but debilitating inflammatory disease and patients with the disease typically have very high levels of eosinophils.

“Our clinical trials for Fasenra in severe, eosinophilic asthma show it depletes eosinophils and we are exploring the potential of this medicine to address unmet medical needs in other eosinophil-driven diseases.”

“Our clinical trials for Fasenra in severe, eosinophilic asthma show it depletes eosinophils.”

AstraZeneca’s first respiratory biologic Fasenra is a monoclonal antibody that binds directly to IL-5 receptor α on eosinophils and attracts natural killer cells to induce rapid, as well as near-complete depletion of eosinophils through apoptosis.

Fasenra is currently approved as an add-on maintenance treatment in severe, eosinophilic asthma in the US, EU, Japan, and several other jurisdictions. Further regulatory reviews are ongoing.

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.

Where approved, the biologic is available as a fixed-dose subcutaneous injection through a prefilled syringe given once every four weeks for the first three doses. Later on, it will be administered once every eight weeks.

The company has not yet started Phase III trials for Fasenra in EGPA, which was formerly known as Churg-Strauss Syndrome. It is characterised by inflammation of blood vessels and the presence of elevated levels of a type of white blood cell known as eosinophils.