The approval was based on data from the Phase III GRECO clinical trial and the Phase I AMES trial.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s self-administered Fasenra (benralizumab) in a pre-filled, single-use auto-injector for severe eosinophilic asthma.
The approval was based on data from the Phase III GRECO clinical trial and the Phase I AMES trial. Their primary objective was usability, for GRECO, and pharmacokinetic (PK) exposure, for AMES. The Fasenra self-administered and Fasenra Pen are also approved in Europe. Fasenra is currently approved in the U.S., EU, Japan and other countries as add-on maintenance for severe eosinophilic asthma.
“Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period,” said Mene Pangalos, AstraZeneca’s executive vice president of BioPharmaceuticals R&D. “Today’s news means we can now offer Fasenra in an even more convenient way, giving U.S. 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.”
The drug is not approved for other eosinophilic conditions or relief of acute bronchospasm or status asmaticus.
GRECO is a Phase III multicenter, open-label, 28-week trial that assessed the functionality, performance and reliability of the pre-filled auto-injector device with Fasenra administered subcutaneously every four weeks in the clinic and in an at-home setting. The patient population was 120 adults with severe, uncontrolled asthma. Most, 97%, of at-home injections by patients or caregivers were successful at weeks 12 and 16, and 96% of the pens that were returned after home use were determined to be still functional at weeks 12 and 16.
AMES is also a multicenter, randomized, open-label, parallel group Phase I trial. This was conducted in healthy individuals to compare the pharmacokinetic exposure after a single dose of Fasenra via pre-filled syringe or pre-filled auto-injector devices. The PK exposure was comparable with both devices and eosinophils were quickly depleted in patients from both groups.
Fasenra is the company’s first respiratory biologic. It is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils. This attracts natural killer cells, causing rapid and near-complete depletion of eosinophils by way of apoptosis, or programmed cell death. The drug was developed by AstraZeneca and in-licensed from BioWa, a wholly owned subsidiary of Kyowa Kirin Co. of Japan.
In 2018, Fasenra brought in $297 million. In August, the FDA granted the drug Orphan Drug Designation (ODD) to treat eosinophilic esophagitis (EoE). EoE is a rare, chronic, inflammatory disease caused by the white blood cells known as eosinophils, to accumulate in the esophagus, which causes injury and inflammation. In November 2018, the FDA also granted ODD for Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA) and in February 2019, granted ODD for the drug for hypereosinophilic syndrome (HES).
“As a clinician, I use Fasenra in my office because of its efficacy and safety data,” said Reynold Panettieri, vice chancellor for Translational Medicine and Science and director of the Rutgers Institute for Translational Medicine and Science. “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.”
