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