AstraZeneca Gets Positive EMA Opinion on Respiratory Biologic

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The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.

On Nov. 10, 2017, AstraZeneca and MedImmune, its biologics research and development arm, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for granting marketing authorization to the companies for their investigational respiratory biologic, benralizumab, as an add-on maintenance treatment for severe eosinophilic asthma that is inadequately controlled despite high-dose inhaled corticosteroids, plus long-acting b-agonists.

The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the 28 European Union member countries plus Iceland, Norway, and Liechtenstein.

Benralizumab is also under regulatory review in the United States, Japan, and several other countries. In the US, the Prescription Drug User-Fee Act date has been set in the fourth quarter of 2017. In other countries, regulatory decisions are expected during the first half of 2018. It is currently not approved anywhere in the world.

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

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said in a company press release: “This positive recommendation is an important step towards providing a next-generation treatment for severe, uncontrolled asthma patients with an eosinophilic phenotype. Benralizumab has the potential to make a real difference to patients with its combination of efficacy, speed of onset, convenience and the ability to reduce oral steroid use.”


Tim Harrison, professor of asthma and respiratory medicine, University of Nottingham, UK, and a trial investigator, added in the release: “Severe, uncontrolled asthma affects millions of people around the world, and many patients experience debilitating symptoms and face increased risk of hospitalizations, emergency room visits and death despite current treatments. Benralizumab is a new kind of precision antibody with proven efficacy and ease of use which will help transform severe asthma care.”

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

Source: AstraZeneca