FDA grants AstraZeneca's new anti-inflammatory drug, Fasenra (benralizumab), as an orphan drug for HES
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, AstraZeneca, thegiant ofpharmaceutical(http:// in the UK, announced that theAuthority for food anddrugs (http:// had granted the new anti-inflammatory drug Fasenra (http://a new anti-inflammatory drug, The Anti-Inflammatory Drug, to treat the orphan drug (HES) for highly acidic granulocytic syndrome (HES)November 2018, the FDA also granted Fasenra the grant for the treatment of eosinophilic granuloma polyvascularitis (EGPA)fasenraFasenra can induce rapid and almost complete depletion of eosinophils, which have been shown to be effective for severe eosinophilic asthma, and that the drug may also benefit treatment patients with HES, the National Institutes of Health (NIH) is currently working with Astra on a Phase II clinical study of Fasenra Therapeutic HES, with results expected later in 2019In the study, Fasenra depleted blood eosinophils in the 12th week of treatment compared to placebo, and there was evidence that eosinophils in affected tissueweres were removed in the 24th week of treatmentFasenra's active pharmaceutical ingredient is benralizumab, a monoclonal antibody that directly binds to alpha sub-base (IL-5R alpha) of the leukocyte interleukin 5 receptor on eosinophils and uniquely attracts naturally killing cells (NK cell), which induces rapid and almost complete depletion of eosinophils through apoptosis (procedural cell death)Fasenra is AstraZeneca's first respiratory student preparation and is currently approved by the United States, the European Union, Japan and several other countries as an additional (add-on) maintenance therapy for the treatment of patients with severe eosinophilic granulocytesmedication, Fasenra can be injected with a fixed dose of subcutaneous injection through a pre-charged syringe, the first 3 injections every 4 weeks and then every 8 weeksFasenra was acquired by AstraZeneca from http:// a wholly-ownedcompany of Japanese pharmaceutical companies, Http://, Astrabes is also evaluating Fasenra's potential to treat severe nasal polypsPhase III clinical study of Fasenra's treatment of HES has not yet been initiated
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