AstraZeneca announced that 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, which achieved their primary objective of usability and pharmacokinetic (PK) exposure, respectively. 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.”
Reynold Panettieri, MD, 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.”
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.
FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
Source: Company Press Release