AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Friday the approval by the US Food and Drug Administration (FDA) of the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen).

The company said this approval is supported by data from the phase III GRECO trial and the phase I AMES trial. The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine.

According to the company, Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period. This approval implies that the company can now offer Fasenra in an even more convenient way, giving US healthcare providers and

patients the option of administering Fasenra at home or in a doctor's office, making treatment more accessible to patients with severe eosinophilic asthma.

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

AMES is a multicentre, randomised, open-label, parallel-group phase I trial in healthy people to compare the pharmacokinetic (PK) exposure following single 30mg SC administration of Fasenra by using pre-filled syringe or pre-filled auto -injector devices.

The US approval of the Fasenra Pen provides healthcare professionals and patients the option for Fasenra to be administered outside of a clinical setting via auto-injector by a patient or caregiver after their healthcare professional decides it is appropriate. The Fasenra pre-filled syringe is available for administration by a healthcare professional. The Fasenra Pen enables patients and caregivers to administer the medicine via a

simple two-step process. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism, and Respiratory.