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Sanofi and Regeneron's Dupixent approved in Japan as the first targeted medicine to treat adults with
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).
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 the regulatory submission in Japan.
Treatment-related adverse events (AEs) occurred in 26% of Dupixent patients and 15% of placebo patients. The treatment-related AE most commonly
reported with Dupixent was conjunctivitis (4%).
In addition to BP, Dupixent is approved in Japan in certain patients with atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD).
BP is a rare skin disease that primarily
affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the
body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a
patient's immune system.
was a randomized, double-blind, placebo-controlled phase 2/3 study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo every two weeks (Q2W) after an initial loading dose, along with OCS treatment. During treatment, OCS
taper was initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued if
disease control was maintained, with the intent of completion by Week 16. After OCS tapering, patients were only treated with Dupixent or placebo for the rest of the study (rescue treatment could be used if required).
The primary endpoint evaluated the proportion of patients achieving sustained disease remission at Week 36. Sustained disease remission was defined as
complete clinical remission with completion of OCS taper by Week 16 without relapse after completion of the OCS taper and no rescue therapy use during the 36-week treatment period. Relapse was defined as
appearance of 3 new lesions a month or 1 large lesion or urticarial plaque (>10 cm in diameter) that did not heal within a week.
Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or re-initiation of OCS after completion of the OCS taper), or systemic non-steroidal immunosuppressive medications or immunomodulating biologics.
Dupixent (dupilumab) is now available in Japan as a 300 mg pre-filled syringe or
pre-filled pen for adults with BP. Dupixent is intended for injection under the skin (subcutaneous injection) and is given Q2W after an initial loading dose. It can be given in a clinic or at home by
self-administration after training by a healthcare professional.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the
interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a
decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often
Dupixent has received regulatory approvals in more than 60 countries in one or more
indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, CSU, COPD, BP, and allergic fungal rhinosinusitis in different age populations. More than 1.4 million patients are being
treated with Dupixent globally.
Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical
studies involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These
potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
Regeneron (NASDAQ: REGN) is a leading
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