Sanofi and Regeneron's Dupixent Approved in Japan for Bullous Pemphigoid

Dupixent becomes first targeted treatment for moderate-to-severe bullous pemphigoid in Japan

Mar. 24, 2026 at 6:21am

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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). The approval was based on data from a pivotal phase 2/3 study showing Dupixent patients experienced over four times more sustained disease remission compared to placebo at Week 36.

Why it matters

BP is a rare, chronic skin disease characterized by intense itch, painful blisters, and lesions. The approval of Dupixent provides a new targeted treatment option for patients in Japan, where available therapies have been limited and can suppress the immune system.

The details

In the LIBERTY-BP-ADEPT study, patients received Dupixent or placebo every two weeks along with oral corticosteroids. During treatment, patients underwent a protocol-defined corticosteroid tapering regimen if disease control was maintained. The primary endpoint showed 18% of Dupixent patients achieved sustained disease remission at Week 36 compared to 4% of placebo patients.

  • Dupixent was approved in Japan on March 24, 2026.
  • The LIBERTY-BP-ADEPT study evaluated Dupixent over a 52-week treatment period.

The players

Sanofi

A global biopharmaceutical company that co-developed Dupixent with Regeneron.

Regeneron

An American biotechnology company that co-developed Dupixent with Sanofi.

Ministry of Health, Labour and Welfare in Japan

The government agency that granted marketing and manufacturing authorization for Dupixent in Japan.

LIBERTY-BP-ADEPT

The pivotal phase 2/3 clinical study that evaluated Dupixent in adults with moderate-to-severe bullous pemphigoid.

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What’s next

Sanofi and Regeneron plan to continue studying Dupixent in additional type 2 inflammatory diseases, including chronic pruritus of unknown origin and lichen simplex chronicus.

The takeaway

The approval of Dupixent in Japan as the first targeted treatment for moderate-to-severe bullous pemphigoid represents an important advancement in managing this rare and burdensome skin condition, providing a new option for patients beyond limited existing therapies.