Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP)
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The FDA has accepted a supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) for priority review. If approved, it will be the first targeted treatment for Bullous Pemphigoid (BP) in the U.S. The FDA decision is expected by June 20, 2025.
February 18, 2025 | 6:15 am
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POSITIVE IMPACT
Regeneron, in collaboration with Sanofi, has its drug Dupixent® under FDA priority review for Bullous Pemphigoid. Approval would make it the first targeted treatment for BP in the U.S., with a decision expected by June 20, 2025.
Regeneron, in partnership with Sanofi, stands to benefit from Dupixent's potential approval as the first targeted treatment for BP in the U.S. This could enhance Regeneron's product portfolio and revenue.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90
POSITIVE IMPACT
Sanofi's Dupixent® (dupilumab) has been accepted for FDA priority review for treating Bullous Pemphigoid. Approval would make it the first targeted treatment for BP in the U.S., with a decision expected by June 20, 2025.
The acceptance of Dupixent for FDA priority review is a significant step for Sanofi, as approval would position Dupixent as the first targeted treatment for BP in the U.S. This could lead to increased market share and revenue for Sanofi.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90