The European Commission has approved Fasenra (benralizumab) as an add-on maintenance treatment in patients with severe eosinophilic asthma. The approval, announced by therapy developer AstraZeneca and its global research and development arm, MedImmune, follows FDA approval of Fasenra in the U.S. in November 2017.
Up to 10 percent of asthma patients suffer from severe asthma, and almost half of those — about 5 percent of all asthma patients — suffer from severe eosinophilic asthma, a condition characterized by high levels of white blood cells known as eosinophils. Patients with severe eosinophilic asthma experience an increase in the risk of exacerbations and a decrease in lung function.
Fasenra acts by binding to proteins on the surface of eosinophils. This binding leads to other immune cells, known as natural killer cells, attacking eosinophils and killing them through a process known as apoptosis, or programmed cell death. The “near-complete depletion” of eosinophils, which is achieved within 24 hours of Fasenra’s administration, results in the reduction of asthma exacerbations and improvement in lung function.
“Fasenra is our first respiratory biologic medicine. Today’s decision from the EC [European Commission] follows the recent approval of Fasenra in the US and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation,” Sean Bohen, chief medical officer at AstraZeneca, said in a press release.
The approved dosing regimen of Fasenra is as a subcutaneous injection once every four weeks for the first three doses, followed by one injection every eight weeks.
The approval follows positive results from the WINDWARD program, which included six Phase 3 clinical trials, including SIROCCO, CALIMA, ZONDA, BISE, BORA, and GREGALE. Three of these trials were considered as pivotal to the program: SIROCCO (NCT01928771), CALIMA (NCT01914757), and ZONDA (NCT02075255).
In SIROCCO and CALIMA, which involved 2,510 patients, the subcutaneous injection of Fasenra in addition to standard treatment resulted in improvements in lung function and a reduction of exacerbations compared to patients who received a placebo with their standard treatment.
The most common adverse reactions included headaches (8 percent) and pharyngitis (3 percent).
In ZONDA, patients who received Fasenra required significantly lower chronic oral corticosteroid therapy compared to those who received placebo treatment.
“Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalizations and death, despite current treatments. I look forward to being able to offer Fasenra as a new anti-eosinophilic monoclonal antibody which has demonstrated efficacy versus placebo in pivotal clinical trials and has the convenience of an 8-week maintenance dosing regimen,” said Tim Harrison, an investigator for the WINDWARD trial program.
Fasenra is also being assessed as a therapy for patients with severe chronic obstructive pulmonary disease (COPD) in a Phase 3 clinical trial (NCT02138916).