Dupixent, bullous pemphigoid and sBLA

FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
As Sanofi and Regeneron await the FDA decision, a legal dispute between the partners over commercialisation details continues.
FDA accepts sBLA, grants priority review for Dupixent to treat bullous pemphigoid
The supplemental biologics license application for Dupixent for the treatment of bullous pemphigoid in adults has been accepted by the FDA for priority review, Sanofi announced in a press release. The acceptance of the Dupixent (dupilumab;
Regeneron, Sanofi Get Speedy FDA Review of Dupixent in Bullous Pemphigoid
Regeneron and Sanofi said an FDA green light would make Dupixent the first targeted medicine in the U.S. for bullous pemphigoid, a debilitating and relapsing skin disease with underlying type 2 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesions.
Dupilumab Under FDA Priority Review for Bullous Pemphigoid
Patients treated with on dupilumab showed significant improvement in sustained BP remission compared with those on placebo.
Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid
Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoidIf approved, Dupixent would be the first and only
Dupilumab Gets Priority Review for Bullous Pemphigoid
Dupilumab, an interleukin-4 receptor antagonist, is expected to decrease the type 2 inflammation seen in bullous pemphigoid.
USFDA grants priority review to Sanofi-Regeneron Dupixent for bullous pemphigoid
Paris: Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to
Regeneron, Sanofi announce Dupixent sBLA accepted for priority review by FDA
Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for
Sanofi and Regeneron’s Dupixent granted FDA priority review for bullous pemphigoid
Sanofi and Regeneron’s Dupixent (dupilumab) has been accepted for priority review by the US Food and Drug Administration (FDA) to treat adults with bullous pemphigoid (BP).
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Pharma Stock Roundup: EU Nod to MRK's Welireg, IONS' Q4 Results & More
This week, the European Commission granted approval to Merck’s MRK novel HIF-2α inhibitor, Welireg, for two indications. The ...
pharmaphorum3d
Can Dupixent plug treatment gap in bullous pemphigoid?
Bullous pemphigoid (BP), which has no FDA-approved targeted therapies, leads to reddening of the skin and the formation of ...
Daily4h
Sanofi nears selling 50 percent controlling stake in Opella to CD&R
Paris: Sanofi and CD&R have announced that they have signed the share purchase agreement in relation to the sale of a 50 ...