The EMA Accepts MAA for GSK’s Depemokimab as an Adjunctive to Treat Asthma with Type 2 Inflammation and CRSwNP
Shots:
- The EMA accepted depemokimab’s MAA as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively. NDA is also accepted by the NMPA & MHLW
- SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed depemokimab vs PBO + SoC, ICS & controller in the above pts and demonstrated reduced exacerbations & hospitalization rates; data was published in The NEJM
- ANCHOR-1 (n=271) & ANCHOR-2 (n=257) trials evaluated depemokimab vs PBO in CRSwNP pts and met its co-1EPs showing reduced nasal polyp size and obstruction VRS mean score at 52wks. Data to be shared at future meetings
Ref: GSK | Image: GSK
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
