AstraZeneca and its global research and development subsidiary MedImmune said Wednesday they got the European Commission’s approval for Fasenra (benralizumab) as an add-on treatment for patients with severe asthma.
Fasenra is an add-on maintenance treatment for patients with severe eosinophilic asthma who suffer from the condition despite taking high-dose inhaled corticosteroids and long-acting beta-agonists.
“Fasenra is our first respiratory biologic medicine. Today’s decision from the EC follows the recent approval of Fasenra in the U.S. and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation,” said Sean Bohen, AstraZeneca’s executive vice president, global medicines development and chief medical officer.
The European approval comes on the heels of the U.S. Food and Drug Administration approval in November for patients with severe asthma aged 12 years and older with an eosinophilic phenotype.
Results from the company’s WINDWARD program, which encompasses several phase-3 trials such as SIROCCO, CALIMA, and ZONDA, proved the drug's efficacy and safety, the company said.
The drug is currently undergoing regulatory review in Japan and other countries. AstraZeneca expects results in the first half this year, it said.
Asthma affects 315 million people globally with around 10 percent suffering from severe asthma.
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