Dupixent® Approved as First Biologic for COPD in Japan

Regeneron Pharmaceuticals, Inc. and Sanofi have recently announced the approval of Dupixent® (dupilumab) in Japan for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose condition is inadequately managed with existing therapies. This authorization by the Ministry of Health, Labour, and Welfare marks a significant milestone as Dupixent becomes the first new COPD treatment introduced in Japan in more than ten years, and adds to its existing approvals for chronic diseases with type 2 inflammation. This achievement follows similar approvals in the European Union, China, and the United States, and is grounded in the pivotal Phase 3 trial results for patients with elevated eosinophils.

The approval was largely based on data from the BOREAS Phase 3 trial, which assessed Dupixent in addition to maximal standard care inhaled therapy, where the majority of participants were on triple therapy, or double therapy for those contraindicated for inhaled corticosteroids. In COPD patients with high blood eosinophil counts, Dupixent demonstrated a notable reduction in exacerbations and enhanced lung function compared to a placebo. Safety profiles were consistent with previous Dupixent indications, with injection site reactions being the most prevalent adverse event. The findings from BOREAS and its counterpart, the NOTUS Phase 3 trial, have been documented in The New England Journal of Medicine.

Chronic obstructive pulmonary disease, a progressive condition that impairs lung function, is the fourth leading cause of death globally. It is characterized by persistent cough, excessive mucus production, and breathlessness, impeding daily activities and often leading to sleep issues, anxiety, and depression. The disease poses substantial health and economic challenges due to recurrent acute exacerbations requiring systemic corticosteroids and antibiotics. Smoking and exposure to harmful particles are prominent risk factors, and individuals may continue experiencing lung damage even after quitting smoking. Approximately half of COPD patients suffer exacerbations despite receiving triple inhaled therapy, with elevated eosinophils increasing hospitalization risks.

Regeneron and Sanofi aim to revolutionize COPD treatment by focusing on the different inflammatory pathways involved in the disease's progression. Their research includes exploring the effects of Dupixent and itepekimab, two biologics targeting various inflammatory pathways. Dupixent represents a unique biologic that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, targeting type 2 inflammation. Meanwhile, itepekimab, still under investigation, is a monoclonal antibody that inhibits interleukin-33 (IL-33), a key player in amplifying inflammation in COPD.

Dupixent is accessible in Japan as a 300 mg dose in pre-filled syringes or pens for subcutaneous injection, administered biweekly. Patients can receive it either in a clinical setting or at home, following proper training. Developed using Regeneron's VelocImmune® technology, Dupixent is a fully human monoclonal antibody, distinct from immunosuppressants. Its clinical program has showcased significant benefits in reducing type 2 inflammation across multiple related chronic diseases.

Regeneron’s VelocImmune technology, which was conceptualized by its co-founder George D. Yancopoulos in 1985, involves a genetically engineered mouse platform with a humanized immune system, facilitating the creation of optimized fully human antibodies. This technology has been instrumental in developing many FDA-approved monoclonal antibodies, including Dupixent®.

Regeneron and Sanofi continue to study Dupixent for various diseases linked to type 2 inflammation or allergic responses. Their extensive research program, encompassing over 60 clinical trials and more than 10,000 patients, investigates potential applications in conditions like chronic pruritus, bullous pemphigoid, and lichen simplex chronicus, although these studies are still in progress and awaiting regulatory evaluation.

Overall, the approval of Dupixent in Japan for COPD signifies an important advancement in addressing chronic diseases with type 2 inflammation, offering new hope for patients with unmet needs in their treatment regimens.