Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen.- AstraZeneca

AstraZeneca announced that the FDA has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen). The 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.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: �Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period. Today�s news means we 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, and making treatment more accessible to patients with severe eosinophilic asthma.�

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

About GRECO and AMES- GRECO is a Phase III multicentre, open?label, 28-week trial designed to assess patient? or caregiver?reported functionality, performance and reliability of a pre-filled auto-injector device with a fixed 30mg dose of Fasenra administered subcutaneously (SC) every four weeks in clinic and in an at?home setting in 120 adults with severe, uncontrolled asthma. The majority (97%) of at-home administrations by patients or caregivers were successful at week 12 and week 16 and nearly all (96%) of the returned pre-filled auto-injector devices used to administer Fasenra at home were evaluated as being functional at week 12 and week 16. 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. Fasenra PK exposure was comparable following SC administration via a pre-filled syringe or a pre-filled auto-injector. Eosinophils were rapidly depleted in patients from both device-type groups.The safety profile in both trials was similar to previous trials, with no new or unexpected safety findings.

About the Fasenra Pen - 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.