EU Approves AstraZeneca’s Respiratory Biologic

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The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

On Jan. 11, 2018, AstraZeneca and MedImmune, its biologics research and development arm, announced that the European Commission (EC) has approved the companies’ respiratory biologic, benralizumab, as an add-on maintenance treatment for adults with severe eosinophilic asthma that is inadequately controlled despite high-dose inhaled corticosteroids, plus long-acting b-agonists.

The biologic was developed by MedImmune and is in-licensed from BioWa, a wholly owned subsidiary of Kyowa Hakko Kirin, a Japanese pharmaceutical company.

In November 2017, FDA approved the biologic for the add-on maintenance treatment of patients with severe asthma aged 12 years and older and with an eosinophilic phenotype. The drug is also under regulatory review in Japan and several other countries, with expected regulatory decisions in the first half of 2018.

Benralizumab is a respiratory biologic that provides direct, rapid, and near-complete depletion of eosinophils, a type of white blood cell, within 24 hours, according to the companies. Elevated levels of eosinophils result in increased severity of asthma, decreased lung function, and increased risk of exacerbations. The biologic binds directly to the interleukin-5α receptor on an eosinophil and attracts natural killer cells to induce apoptosis.


Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said in a company press release: “Fasenra [benralizumab] is our first respiratory biologic medicine. Today’s decision from the EC follows the recent approval of Fasenra [benralizumab] in the [United States] and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation.”

Source: AstraZeneca