Regeneron & Sanofi Report the US FDA Acceptance of sBLA for Priority Review of Dupixent (dupilumab) to Treat Prurigo Nodularis
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
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.
