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EMA committee recommends marketing approval for AstraZeneca's benralizumab for severe, uncontrolled eosinophilic asthma

United Kingdom
Monday, November 13, 2017, 17:00 Hrs  [IST]

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation of benralizumab as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting b-agonists.

Sean Bohen, Executive Vice President, Global Medicines Development and chief medical officer at AstraZeneca, said: “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.”

The CHMP recommendation is based on results from the WINDWARD programme, including the pivotal phase III exacerbation trials, SIROCCO and CALIMA, and phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the 8-week dosing benralizumab regimen from these trials showed: Up to 51% reduction in the annual asthma exacerbations rate (AERR) versus placebo, Rapid improvement in lung function (290mL increase in forced expiratory volume in one second (FEV1) from baseline at 4 weeks) after the first dose, providing an early indication of effectiveness,    75% median reduction in daily OCS use and discontinuation of OCS use in 52% of eligible patients,     An overall adverse event profile similar to placebo

Tim Harrison, Professor of Asthma and Respiratory Medicine, University of Nottingham, UK, and CALIMA trial investigator, said: “Severe, uncontrolled asthma affects millions of people around the world, and many patients experience debilitating symptoms and face increased risk of hospitalisations, 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 the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours. Eosinophils are a type of white blood cell that are a normal part of the body's immune system. Elevated levels of eosinophils, seen in about half of severe asthma patients, impact airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function and increased risk of exacerbations.

Benralizumab binds directly to the IL-5a receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). If approved, benralizumab will be available as a once every 8-week fixed-dose subcutaneous injection via a prefilled syringe.

A recent pooled analysis of the SIROCCO and CALIMA trials identified specific, well-defined characteristics of an eosinophilic phenotype that will allow clinicians to more precisely select the severe asthma patients most likely to receive maximum benefit from treatment with benralizumab.

The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 EU member countries plus Iceland, Norway and Liechtenstein.

Benralizumab is also under regulatory review in the US, Japan and several other countries, with a US PDUFA date during the fourth quarter of 2017 and expected regulatory decisions elsewhere during the first half of 2018.

 

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