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Nucala Approved for Chronic Rhinosinusitis With Nasal Polyps Credit: GlaxoSmithKline The Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. The approval was based on data from the randomized, double-blind, parallel group phase 3 SYNAPSE study (ClinicalTrials.gov Identifier: NCT03085797), which evaluated the efficacy and safety of mepolizumab, an interleukin-5 antagonist monoclonal antibody, as an add-on maintenance treatment in over 400 adults with CRSwNP. All patients had a history of prior surgery and were in need of further surgery due to severe symptoms and increased size of their polyps. Patients were randomly assigned to receive mepolizumab 100mg subcutaneously every 4 weeks or placebo for 52 weeks, in addition to standard of care (eg, mometasone furoate nasal spray).

Hal barronResearch triangle parkDrug administrationChief scientific officerஹால் பரோன்ஆராய்ச்சி முக்கோணம் பூங்காதலைமை அறிவியல் அதிகாரி