Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid
Shots:
- The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.
- Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks. 4 to 6 if disease control was sustained, with the intent of completion by 16wks., after which pts continued on Dupixent or PBO alone for the rest of the trial
- Trial showed 18% vs 4% of the pts sustained disease remission (1EP) at 36wks., with favorable safety
Ref: Regeneron | Image: Regeneron & Sanofi |Press Release
Related News: The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)
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