Regulatory Affairs

AstraZeneca’s Fasenra gets approval in Europe for severe eosinophilic asthma

PBR Staff Writer Published 11 January 2018

AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.

The approval is for the treatment of adult patients in whom the condition is inadequately controlled even after being subjected to high-dose inhaled corticosteroids and long-acting beta-agonists.

The EC granted the approval based on the findings of the WINDWARD study, comprised of six phase 3 trials including the pivotal SIROCCO and CALIMA exacerbation trials, and the OCS-sparing trial, ZONDA.

AstraZeneca chief medical officer and global medicines development executive vice president Sean Bohen said: “Fasenra is our first respiratory biologic medicine. Today’s decision from the EC 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.”

Fasenra is a monoclonal antibody that uses natural killer cells to induce direct, fast and almost-complete depletion of eosinophils.

In about half of severe asthma patients, eosinophils are found to be to be too high, resulting in increased severity and symptoms of their condition, reduced lung function and higher risk of exacerbations.

University of Nottingham asthma and respiratory medicine professor Tim Harrison, who was also an investigator in the WINDWARD trial program, said: “Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations 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.”

Fasenra, which was developed by AstraZeneca with its global biologics research and development arm MedImmune, was approved in the US in November 2017 for the treatment of severe eosinophilic asthma.

The approval is for the drug to be used as an add-on maintenance treatment for adult patients with severe asthma with an eosinophilic phenotype.

Image: AstraZeneca’s Fasenra has now been approved in both the US and European Union (EU) for severe eosinophilic asthma. Photo: courtesy of AstraZeneca.