FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Fasenra (benralizumab)

Indication:

For add-on maintenance treatment of severe asthma in patients with an eosinophilic phenotype aged 12 years or older.

Mechanism:

Interleukin (IL)-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa). The IL-5 receptor is expressed on the surface of eosinophils and basophils. It reduces eosinophils and basophils through antibody-dependent cell-mediated cytotoxicity (ADCC).

Dosage:

30 mg SC q4weeks for the first 3 doses, THEN q8weeks thereafter.

Approval:

Approval was based on three phase 3 studies (ie, CALIMA, SIROCCO, ZONDA), which demonstrated the following:

  • Up to 51% reduction in the annual asthma exacerbation rate vs placebo.

  • Significant improvement in lung function as measured by forced expiratory volume in 1 second of up to 159 mL vs placebo, with differences seen as early as 4 weeks after the first dose.

  • 75% median reduction in daily oral corticosteroid use and discontinuation of oral corticosteroid use in 52% of eligible patients.

  • An overall adverse event profile similar to that of placebo.

References:

FitzGerald JM, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. CALIMA Trial Investigators. Lancet. 2016 Oct29;388(10056):2128-41.

SIROCCO Study Investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-27.

ZONDA Trial Investigators. Oral glucocorticoid-sparing effect of benralizumab in severe asthma. N Engl J Med. 2017 Jun 22;376(25):2448-58.

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