BRIEF—Health Canada approves Fasenra

Health Canada has approved Fasenra (benralizumab injection) as an add-on maintenance treatment for adult patients with severe eosinophilic asthma from Anglo-Swedish pharma major AstraZeneca.

Fasenra was approved in the USA in November 2017 and last month in Europe. The drug is in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin, and is also being evaluated in chronic obstructive pulmonary disease.

"Treatment options for patients with severe eosinophilic asthma are limited, with many relying on oral steroids to manage their symptoms, which can lead to considerable side effects," said Dr Mark FitzGerald, director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute, University of British Columbia, and Principal Investigator of the CALIMA trial.

Fasrena’s approval means physicians have a new option for severe asthma patients with a distinct phenotype," said Dr. FitzGerald. "Its strong clinical profile offers patients the potential to experience fewer asthma attacks and thus avoid the use of oral corticosteroids, and in those patients requiring oral corticosteroids on a regular basis, the ability to reduce or even stop their use of oral corticosteroids."

The Health Canada approval is based on results from the WINDWARD clinical program, including the pivotal Phase III exacerbation trials.