Business

Press Release: Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid

Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid Approval in moderate-to-severe patients was based on pivotal study results showing over four times more Dupixent patients experienced sustained disease remission through Week 36 compared with placeboBP is a chronic, relapsing skin disease with underlying type 2 inflammation characterized by intense itch alongside painful blisters and other lesionsBP is the seventh approved ind

articleRegeneron Pharmaceuticals, Inc.March 24, 202614/company/regeneron-pharmaceuticals-inc/news/press-release-sanofi-and-regenerons-dupixent-approved-in-japan-as-the-first-targeted-medicine-to-treat-adults-with-bullous-pemphigoid-1
Press Release: Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid

About this update from Regeneron Pharmaceuticals, Inc.

[{"type":"image","alt":"Sanofi Winthrop Industrie","displaySize":"","headline":null,"caption":"Sanofi Winthrop Industrie","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":84,"url":"https://media.zenfs.com/en/globenewswire.com/c45c40f5ed741dd9c0f5c2f75b8fc137"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/739gYr0oCQk4PhnczLgzIQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExOA--/https://media.zenfs.com/en/globenewswire.com/c45c40f5ed741dd9c0f5c2f75b8fc137","width":300,"height":84}},"lazy":false},{"type":"text","content":"Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid","length":120,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Approval in moderate-to-severe patients was based on pivotal study results showing over four times more Dupixent patients experienced sustained disease remission through Week 36 compared with placebo","length":199,"tagName":"p"}]},{"val":[{"type":"text","content":"BP is a chronic, relapsing skin disease with underlying type 2 inflammation characterized by intense itch alongside painful blisters and other lesions","length":150,"tagName":"p"}]},{"val":[{"type":"text","content":"BP is the seventh approved indication for Dupixent in Japan","length":59,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":408,"olType":false},{"type":"text","content":"Paris and Tarrytown, NY, March 24, 2026. The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP).","length":248,"tagName":"p"},{"type":"text","content":"The approval in Japan is based on data from the pivotal LIBERTY-BP-ADEPT phase 2/3 study (clinical study identifier: NCT04206553), which evaluated Dupixent in adults with moderate-to-severe BP. Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. For the primary endpoint, more than four times as many patients on Dupixent experienced sustained disease remission compared to placebo (18% vs. 4%; p=0.0250) at Week 36 in the companies’ core dataset used for t...

More updates from Regeneron Pharmaceuticals, Inc.

OCSchronic rhinosinusitisSanofi