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GSK’s Nucala (Mepolizumab) Secures the NMPA’s Approval for Treating Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

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  • The NMPA has approved Nucala as an add-on therapy with intranasal corticosteroids in CRSwNP adults with inadequately controlled disease. It is approved for patients (≥12yrs.) as an add-on treatment of severe eosinophilic asthma & for adults having eosinophilic granulomatosis with polyangiitis
  • Approval was based on 2 P-III studies: MERIT assessing Nucala vs PBO in Japanese, Chinese & Russian subjects for 52wks. and SYNAPSE involving >400 subjects with this indication
  • MERIT study, involving 163 patients, showed significantly improved nasal obstruction VAS score (mean difference: -1.43), QoL by SNOT-22 (difference: -10.63) & loss of smell VAS score (difference: -0.82) as well as reduced nasal polyp score at wk.52

Ref: GSK | Image: GSK

Related News:- GSK Reports the Data from the P-III (FIRST-ENGOT-OV44) Study Evaluating Zejula and Jemperli in 1L Advanced Ovarian Cancer

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