The U.S. Food and Drug Administration has approved Fasenra (benralizumab) as an add-on maintenance treatment for people 12 years and older with severe asthma.
In this case, the authorization is for asthma stemming from an over-abundance of immune cells known as eosinophils. Excessive levels of the cells lead to inflammation.
Fasenra is a monoclonal antibody that recruits natural killer cells to wipe out most of the body’s eosinophils.
Elevated levels of eosinophils are seen in about half of those with severe asthma. They lead to airway inflammation and airway hyper-responsiveness that worsen asthma and lung function, and increase the risk of asthma flare-ups.
Fasenra can nearly eliminate eosinophils in 24 hours, clinical trials have shown.
The companies that developed the therapy, AstraZeneca and MedImmune, evaluated its safety and effectiveness in a set of six Phase 3 clinical trials collectively known as the WINDWARD program. The names of the trials were SIROCCO (NCT01928771), CALIMA (NCT01914757), ZONDA (NCT02075255), BISE (NCT02322775), BORA (NCT02258542) and GREGALE (NCT02417961).
Fasenra significantly improved asthma patients’ lung function and cut their flare-ups in half. It also led to a 75 percent reduction in patients’ daily use of steriods. Although effective, steroids can cause health damage over the long term.
“We’re excited to offer Fasenra as a new precision biologic to help improve the lives of severe asthma patients whose disease is driven by eosinophilic inflammation,” Pascal Soriot, the chief executive officer of AstraZeneca, said in a press release. “This is the first approval from our respiratory biologics portfolio and the latest in a series of significant milestones for our company.”
Researchers discovered no safety problems in the trials’ eight-week Fasenra regimen. Adverse events were similar to those seen in the placebo.
The approval means that asthma patients in the United States will be able to take Fasenra by injection once every eight weeks.
“This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms,” said Dr. Eugene Bleecker, the lead investigator of the SIROCCO study.
“Fasenra has a strong clinical [treatment] profile which includes the ability to show lung function improvement after the first dose, the potential to reduce — or even stop — oral steroid use, and the convenience of eight-week dosing,” he said. “Fasenra also treats a distinct patient phenotype [one with a specific set of characteristics], helping physicians select the right patient in clinical practice with more confidence.”
On November 10, 2017, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Fasenra’s marketing authorization in the European Union. Regulators in Japan and other countries are also considering approving the therapy.
Similar to WINDWARD, a Phase 3 VOYAGER clinical trial program is under way to evaluate Fasenra’s safety and ability to treat people with severe chronic obstructive pulmonary disease.