The US Food and Drug Administration (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.
“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,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
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.1 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.2 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 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.
Photo of Mene Pangalos: AstraZeneca