Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). This potential new indication is based on encouraging results from two Phase 3 trials. The FDA’s target action date for Priority Review decision is June 27, 2024. Concurrently, regulatory submissions for this indication are under review in China and Europe.
Dupixent, a pioneering biologic therapy with a proven track record across its FDA-approved indications, has emerged as a beacon of hope in the treatment landscape of chronic obstructive pulmonary disease (COPD). The promising potential exhibited by Dupixent in COPD marks a significant milestone in the field of respiratory medicine. If granted approval, Dupixent would not only stand as a groundbreaking therapeutic option for COPD but also signify a watershed moment as the sole biologic therapy available for this debilitating condition. Furthermore, its approval would signify the first novel treatment approach for COPD in over a decade, underscoring the urgent need for innovative interventions to address the unmet medical needs of COPD patients.
The recognition of Dupixent’s efficacy in COPD reflects the culmination of extensive research and development efforts aimed at revolutionizing the management of respiratory disorders. With its multifaceted mechanism of action and demonstrated clinical benefits in various inflammatory conditions, Dupixent represents a paradigm shift in the treatment of COPD. Its potential approval for COPD would not only expand the therapeutic armamentarium for healthcare providers but also offer renewed hope and improved outcomes for patients grappling with this progressive lung disease.
The pivotal role envisioned for Dupixent in COPD underscores the transformative impact of biological therapies in reshaping the treatment landscape of chronic diseases. By targeting specific pathways implicated in COPD pathogenesis, Dupixent holds the promise of mitigating disease progression, alleviating symptoms, and enhancing the overall quality of life for COPD patients. Moreover, its unique mechanism of action offers a differentiated approach to disease management, offering new avenues for personalized and precision medicine in COPD care.
The potential approval of Dupixent for COPD represents a culmination of years of scientific innovation, clinical research, and collaborative efforts between industry stakeholders, regulatory authorities, and healthcare providers. It underscores the commitment of pharmaceutical companies such as Regeneron Pharmaceuticals, Inc. and Sanofi to advancing medical science and addressing the unmet needs of patients with chronic respiratory conditions. Furthermore, it serves as a testament to the transformative power of biological therapies in ushering in a new era of personalized medicine and precision healthcare.
Dupixent’s Clinical Success and FDA Priority Review Signal a New Era in Treatment
As the global burden of COPD continues to rise, fueled by factors such as aging populations, environmental pollutants, and smoking-related lung damage, the need for effective therapeutic interventions has never been more urgent. Dupixent’s potential approval for COPD offers a ray of hope for millions of patients worldwide who grapple with the debilitating effects of this progressive lung disease. By harnessing the power of biological innovation, Dupixent has the potential to redefine the treatment paradigm for COPD and pave the way for a brighter, healthier future for patients and healthcare systems alike.
The sBLA submission and regulatory filings worldwide are supported by comprehensive data from the Phase 3 COPD clinical research program. This program evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD who exhibited evidence of type 2 inflammation, indicated by elevated blood eosinophils (≥300 cells per μL). Patients enrolled in these trials were already receiving maximal standard-of-care inhaled therapy, with nearly all on triple therapy.
Both Phase 3 trials, known as BOREAS and NOTUS, successfully met their primary endpoint, demonstrating that Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by 30% and 34%, respectively, compared to placebo. Moreover, Dupixent treatment led to rapid and sustained improvements in lung function over the 52-week study period. The safety profile of Dupixent observed in these trials was consistent with its known profile across other approved indications. Common adverse events associated with Dupixent included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Priority Review designation is granted to therapies that have the potential to significantly improve the treatment, diagnosis, or prevention of serious conditions. The potential use of Dupixent in COPD represents a critical area of clinical need, although its safety and efficacy for this indication are still being evaluated.
Dupixent and the Quest for Innovative Treatments in the Face of Growing Challenges
Chronic obstructive pulmonary disease (COPD) is a debilitating respiratory condition characterized by progressive lung function decline. Symptoms include persistent cough, breathlessness, and excessive mucus production, severely impacting patients’ quality of life and leading to various complications such as anxiety, depression, and sleep disturbances. Despite the significant burden of chronic obstructive pulmonary disease, there have been no new treatment approaches approved for over a decade. In the United States alone, approximately 300,000 people live with uncontrolled chronic obstructive pulmonary disease associated with evidence of type 2 inflammation.
Regeneron and Sanofi’s chronic obstructive pulmonary disease clinical research program aims to revolutionize the treatment landscape by exploring the role of different types of inflammation in disease progression. In addition to Dupixent, the program includes the investigation of itepekimab, a potential first-in-class biologic that targets interleukin-33 (IL-33), a key initiator of broad inflammation in chronic obstructive pulmonary disease. Itepekimab is currently undergoing Phase 3 trials, and its safety and efficacy are yet to be evaluated by regulatory authorities.
Dupixent, developed using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways without suppressing the immune system. Its clinical benefits extend to a range of diseases characterized by type 2 inflammation, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, and chronic spontaneous urticaria (CSU). With regulatory approvals in over 60 countries, Dupixent has emerged as a pivotal therapeutic option for patients suffering from these conditions.
Regeneron’s VelocImmune® technology, developed over decades of research, enables the production of optimized fully human antibodies using genetically engineered mice. This technology has been instrumental in creating several FDA-approved monoclonal antibodies, including Dupixent.
The joint development of Dupixent by Regeneron and Sanofi underscores their commitment to addressing unmet medical needs across various chronic diseases driven by type 2 inflammation or other allergic processes. Currently, Dupixent is being evaluated in Phase 3 trials for potential use in additional indications, including chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, and bullous pemphigoid. However, the safety and efficacy of Dupixent in these conditions are still under investigation and have not been fully evaluated by regulatory authorities.
Resource: Investor Regeneron, February 23, 2024
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