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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