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Fasenra Receives FDA Approval for Severe Eosinophilic Asthma

First respiratory biologic with an eight-week maintenance dosing schedule

Benralizumab (Fasenra, AstraZeneca/MedImmune) has secured  FDA approval for the add-on maintenance treatment of patients with severe asthma 12 years of age and older with an eosinophilic phenotype.

The FDA approval is based on results from the WINDWARD program, including the pivotal phase 3 exacerbation trials, SIROCCO and CALIMA, and the phase 3 oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the eight-week benralizumab dosing regimen from these trials showed:

  • Up to 51% reduction in the annual asthma exacerbation rate (AAER) versus placebo
  • Significant improvement in lung function as measured by forced expiratory volume in one second (FEV1) of up to 159 mL versus placebo. Differences were seen as early as four 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 that of placebo

 “This is an important day for severe, eosinophilic asthma patients who have had limited treatment options for far too long, with many relying on oral steroids to manage their symptoms,” said Eugene Bleecker, MD, Professor and Co-Director of Genetics, Genomics and Precision Medicine at the University of Arizona Health Sciences and lead investigator of the pivotal phase 3 SIROCCO study. “Fasenra has a strong clinical profile, which includes the ability to show lung function improvement after the first dose, the potential to reduce—or even stop—oral steroid use, and the convenience of eight-week dosing.”

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 is a monoclonal antibody that binds directly to the IL-5-alpha receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis. Benralizumab will be available as a once-every-eight-week fixed-dose subcutaneous injection via a prefilled syringe.

Benralizumab will be available as a subcutaneous injection via a prefilled syringe administered once every four weeks for the first three doses, and then once every eight-weeks thereafter.

The WINDWARD programme in asthma is made up of six phase 3 trials, including SIROCCO, CALIMA, ZONDA, BISE, BORA, and GREGALE. The two pivotal trials, SIROCCO and CALIMA, are randomized, double-blinded, parallel-group, placebo-controlled trials designed to evaluate the efficacy and safety of subcutaneous administration of Benralizumab (fixed 30-mg dose) for up to 56 weeks in exacerbation-prone adult and adolescent patients 12 years of age and older.

A total of 2,510 patients (1,204 in SIROCCO and 1,306 in CALIMA) received standard-of-care medicine (including high-dosage inhaled corticosteroids and long-acting beta2-agonists) and were randomized globally to receive either Benralizumab 30 mg every four weeks; Benralizumab 30 mg every four weeks for the first three doses followed by 30 mg every eight weeks; or placebo administered via subcutaneous injection using an accessorised pre-filled syringe.

Source: AstraZeneca/MedImmune; November 15, 2017.

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