Dupixent approved as the first targeted medicine to treat adults with bullous pemphigoid in Japan

Sanofi announces that the Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent for the treatment of adults with moderate-to-severe bullous pemphigoid.

Note that this approval in Japan is based on data from the pivotal LIBERTY-BP-ADEPT phase 2/3 study, which evaluated Dupixent in adults with moderate-to-severe BP. Patients were randomised to receive Dupixent 300 mg or placebo added to standard-of-care oral corticosteroids. All patients underwent a protocol-defined OCS tapering regimen if disease activity remained controlled. For the primary endpoint, more than four times as many patients on Dupixent achieved sustained disease remission than those on placebo at Week 36 in the company’s core dataset used for the regulatory submission in Japan.

In addition, the treatment-related adverse events occurred in 26% of Dupixent patients and 15% of placebo patients. The treatment-related AE most commonly reported with Dupixent was conjunctivitis.

Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.

---

---

Related Topics and Keywords

bullous pemphigoid, Dupixent, Regeneron, Sanofi