November 15, 2017 Source: businessinsider 221
AstraZeneca and its global biologics research and development arm, MedImmune, said Tuesay that the US Food and Drug Administration has approved FASENRA (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
FASENRA is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours, as observed in a Phase II study. 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.
FASENRA binds directly to the IL-5a receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis (programmed cell death). FASENRA will be available as a subcutaneous injection via a prefilled syringe administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter.
On November 10, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization of benralizumab. Benralizumab is also under regulatory review in Japan and several other countries.By Ddu
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