Compound Name:MepolizumabMolecular Target:IL-5Molecular Structure:Humanized IgG1? monoclonal antibodyLicensed Indication:severe eosinophilic asthma in patients aged 12 years or olderManufacturer and/or Distributor:GlaxoSmithKlineInitial FDA Approval:2015Summary:Mepolizumab (Nucala) is the first approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. It is administered as a 100 mg fixed dose subcutaneous injection every four weeks. Mepolizumab was licensed in November 2015 as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus. The mepolizumab Phase II/III clinical development program involved nine studies and over 1,300 patients. Three key clinical trials – DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) –established the efficacy and safety profile of Nucala. Patients who were shown to benefit from treatment with mepolizumab in the Phase III clinical trials were those with blood eosinophil levels of 150 cells/µL or greater just prior to treatment. Systemic allergic/hypersensitivity reactions were reported by 1% of subjects who received Nucala compared to 2% of subjects in the placebo group. Manifestations included rash, pruritus, headache, and myalgia. The most common adverse reactions (≥3% and more common than placebo) reported in the first 24 weeks of two clinical trials with Nucala (and placebo) were headache, injection site reaction, back pain, fatigue, influenza, urinary tract infection, upper abdominal pain, pruritis, eczema, and muscle spasm. Herpes zoster infections have occurred in patients receiving Nucala.References

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