AstraZeneca has bagged approval from the US Food and Drug Administration (FDA) for the self-administration of FASENRA (benralizumab) through FASENRA Pen, a pre-filled, single-use auto-injector, for the add-on maintenance treatment of severe asthma in patients aged 12 years and older, and with an eosinophilic phenotype.
FASENRA is a monoclonal antibody which directly binds to the IL-5 receptor alpha on eosinophils and draws natural killer cells towards it to trigger rapid and almost-complete depletion of eosinophils through programmed cell death.
The respiratory biologic has approval as an add-on maintenance treatment for patients with severe eosinophilic asthma in the US, European Union, Japan, and other countries.
Reynold Panettieri – Vice Chancellor for Translational Medicine and Science and Director of Rutgers Institute for Translational Medicine and Science 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.”
The approval for self-administration of the respiratory biologic through FASENRA Pen is backed by the findings of the phase 3 GRECO clinical trial and the phase 1 AMES clinical trial, which achieved their primary goal of usability and pharmacokinetic (PK) exposure, respectively. FASENRA’s safety and tolerability in the two clinical trials were in line with the known profile of the drug, said AstraZeneca.
Mene Pangalos – AstraZeneca 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 does not have approval for other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.