FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries
Image: US FDA has approved FASENRA self-administration using pre-filled syringe. Photo: Courtesy of AstraZeneca.
UK-based biopharmaceutical company AstraZeneca has secured the US Food and Drug Administration (FDA) approval for self-administration of FASENRA (benralizumab) through a pre-filled, single-use auto-injector, FASENRA Pen.
AstraZeneca said that the FDA approval is based on the positive data from Phase III GRECO trial and the Phase I AMES trial, which evaluated the usability and pharmacokinetic (PK) exposure, respectively. The results from the studies showed consistent safety and tolerability of FASENRA.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos 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.”
FDA approves self-administration of FASENRA through auto-injector device
FASENRA (benralizumab) is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils through programmed cell death (apoptosis).
FASENRA is the first respiratory biologic from AstraZeneca, to be approved as an add-on maintenance treatment in severe eosinophilic asthma in the US, EU, Japan and other countries, with further regulatory reviews ongoing.
Following the self-administration approval, the company is offering FASENRA both as a fixed-dose in 30mg SC through pre-filled, single-use syringe, or as FASENRA Pen, in a 29-gauge needle administered once every four weeks for the first three doses and once every eight weeks thereafter.
The company said that the US approval of FASENRA Pen provides an option to administer FASENRA outside of a clinical setting, through an auto-injector.
In addition, FASENRA pre-filled syringe is allowed to be administered by a healthcare professional and is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
Translational Medicine and Science vice chancellor Reynold Panettieri said: “As a clinician, I use FASENRA in my office because of its efficacy and safety data. The importance of this approval is that my patients and I now have another option to personalize their treatment approach to help meet their needs and fit their lifestyle.”