Shots:
- The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & China
- 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 ≥20wks.
- During FDA review, analyses were updated, which showed 18.3% vs 6.1% pts achieved sustained disease remission (1EP), 38.3% vs 10.5% achieved meaningful itch reduction, & the median cumulative OCS dose was 2.8 vs 4.1g at 36wks.
Ref: Sanofi | Image: Regeneron & Sanofi| Press Release
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