Regeneron Pharmaceuticals, Inc.

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

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📄 Japan's Ministry of Health, Labour and Welfare approved Dupixent for adults with moderate-to-severe bullous pemphigoid (BP), marking its first targeted treatment indication in this region.

🏥 This represents the seventh approved indication for Dupixent (dupilumab) in Japan, joining treatments for atopic dermatitis, asthma, and other type 2 inflammation-driven diseases.

📊 The approval relies on pivotal LIBERTY-BP-ADEPT study data showing over four times more patients achieved sustained disease remission at Week 36 with Dupixent versus placebo (18% vs. 4%).

💉 Treatment involves subcutaneous injection every two weeks after an initial loading dose, allowing administration in a clinic or via self-administration at home.

🩹 Most patients receive Dupixent alongside standard-of-care oral corticosteroids, which are tapered after two weeks of sustained disease control is maintained.

⚠️ Treatment-related adverse events occurred in 26% of Dupixent patients compared to 15% on placebo, with conjunctivitis being the most common (4%).

👵 BP primarily affects elderly patients and is characterized by intense itching, painful blisters, and skin lesions that can lead to infection and impaired daily functioning.

🧬 As a fully human monoclonal antibody, Dupixent inhibits IL-4 and IL-13 pathways without acting as an immunosuppressant, targeting type 2 inflammation specifically.

🌍 Sanofi and Regeneron are jointly developing Dupixent, which is already approved in over 60 countries for more than 60 clinical indications treating more than 1.4 million patients globally.

🔬 Phase 3 studies of the drug have established IL-4 and IL-13 as central drivers of type 2 inflammation involved in multiple chronic diseases.

📈 The pivotal study evaluated 106 adults for a 52-week treatment period, utilizing rescue therapies like high-potency topical corticosteroids if needed during the trial.

🛡️ Unlike older treatments, Dupixent does not suppress the patient's immune system broadly, potentially reducing long-term disease burden associated with immunosuppression.

Bullish Signals
  • Dupixent (dupilumab) has received marketing authorization from Japan's Ministry of Health, Labour and Welfare as the first targeted medicine approved for treating adults with moderate-to-severe bullous pemphigoid.
  • Pivotal study results demonstrated over four times more patients on Dupixent achieved sustained disease remission through Week 36 compared to placebo (18% vs. 4%).
  • This marks BP as the seventh approved indication for Dupixent in Japan, expanding its presence in a market where it is already used for atopic dermatitis, asthma, CRSwNP, prurigo nodularis, CSU, and COPD.
  • With over 1.4 million patients being treated with Dupixent globally across more than 60 countries, the drug has a strong track record of clinical benefit and decreased type 2 inflammation.
  • Dupixent is available as a 300 mg pre-filled syringe or pen for self-administration at home, offering convenience after an initial loading dose with injections every two weeks.
Risk Factors
  • Treatment-related adverse events occurred in 26% of Dupixent patients versus 15% of placebo patients, with conjunctivitis reported in 4% of treated individuals.
  • The primary study endpoint measured sustained disease remission by Week 36, requiring completion of oral corticosteroid (OCS) tapering by Week 16 and no rescue therapy use for a full 36-week treatment period, which may limit generalizability to patients who cannot tolerate steroid withdrawal or frequent relapses.
  • Rescue therapy was permitted during the study if disease control was lost, including high-potency topical corticosteroids, systemic non-steroidal immunosuppressive medications, or other biologics, indicating that a significant number of patients may require additional interventions beyond Dupixent alone.
  • Bullous pemphigoid (BP) is characterized by intense itch, painful blisters, and lesions that can result in skin breaking down and increased infection risk, meaning treatment failures or lack of adherence could lead to serious complications even with approved therapy.
Full Analysis
The Ministry of Health, Labour and Welfare in Japan has approved Dupixent (dupilumab), developed jointly by Sanofi and Regeneron, as a first-in-class targeted medicine for adults with moderate-to-severe bullous pemphigoid (BP). This marks the seventh approved indication for Dupixent in Japan. The approval is predicated on findings from the pivotal LIBERTY-BP-ADEPT phase 2/3 study, which identified that over four times as many patients treated with Dupixent achieved sustained disease remission through Week 36 compared to those receiving a placebo. In the core dataset used for the Japanese submission, 18% of Dupixent patients reached the primary endpoint versus 4% in the placebo group, with a statistically significant p-value of 0.0250. Bullous pemphigoid is a rare, chronic, and relapsing skin disease primarily affecting elderly patients, characterized by intense itch, painful blisters, lesions, and skin reddening caused by underlying type 2 inflammation. The ADEPT study evaluated the drug in 106 adults with moderate-to-severe BP over a 52-week period, randomizing participants to receive Dupixent 300 mg or placebo added to standard-of-care oral corticosteroids (OCS). All patients underwent a protocol-defined OCS tapering regimen if disease activity was controlled, beginning between four to six weeks after randomization and intending completion by Week 16. Sustained disease remission was defined as complete clinical remission with OCS taper completion by Week 16 without relapse or the need for rescue therapy. Safety data from the study indicated that treatment-related adverse events occurred in 26% of Dupixent patients compared to 15% of placebo patients. The most commonly reported treatment-related adverse event was conjunctivitis, observed in 4% of Dupixent patients. Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 pathways without acting as an immunosuppressant. The medication is administered via subcutaneous injection every two weeks following an initial loading dose, available in pre-filled syringes or pens for self-administration. Globally, Dupixent is already approved in more than 60 countries for various indications, treating over 1.4 million patients, with ongoing research into additional uses driven by type 2 inflammation or allergic processes.