GSK Reports the MHLW Acceptance of sNDA for Nucala (mepolizumab) in Adults with Chronic Rhinosinusitis with Nasal Polyps
Shots:
- The sNDA was based on the P-III trial (MERIT) evaluating mepolizumab in Japanese, Chinese & Russian patients over a 52wk. period as well as data from the P-III study (SYNAPSE) of mepolizumab vs PBO in 400+ patients with CRSwNP
- The 1EPs of the study were changes from baseline in total endoscopic nasal polyp score at 5wk. and change from baseline in mean nasal obstruction VAS score during 4wks. before 52wk. The co-1EPs were met, and the efficacy & safety of mepolizumab in the Japanese population were consistent with results from global trials
- Nucala, an mAb targeting IL-5 was approved in Japan for bronchial asthma in children aged ≥6yrs.; in adults with refractory asthma & for EGPA. If mepolizumab is approved, it will be 1st anti-IL-5 biologic for adult patients with CRSwNP in Japan
Ref: GSK | Image: GSK
Related News:- GSK Reports the NMPA Acceptance of NDA for Nucala (mepolizumab) to Treat Severe Eosinophilic Asthma
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
