Shots:
The sBLA was based on the two P-III (PRIME2 and PRIME) trials evaluating Dupixent with/out topical treatments vs PBO in 160 & 151 patients aged ≥18yrs. with uncontrolled PN. The US FDA’s decision is expected on Sept 30, 2022
Both trials met their 1EPs & 2EPs i.e., improvement in disease signs & symptoms including a reduction in itch and skin lesions. The safety results were generally consistent with the known safety profile of Dupixent in AD
Dupixent is a fully human mAb that inhibits the signaling of IL-4 and IL-13 pathways & is approved in the US, EU, Japan & other countries globally for AD, asthma, CRSwNP & EoE. The regulatory filings are expected to be planned in 2022 outside of the US
Ref: Sanofi | Image: Sanofi
