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FDA Review Extended for Dupixent in COPD Treatment

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The FDA has extended the priority review for Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD with type 2 inflammation. The new target action date is September 27, 2024. This extension follows additional efficacy analyses from the BOREAS and NOTUS trials, which were submitted earlier in May. The FDA has not raised any concerns regarding Dupixent’s approvability for this indication, reflecting confidence in the data provided. Sanofi and Regeneron remain committed to working closely with the FDA to bring this innovative treatment to patients in need.

The BOREAS and NOTUS phase 3 studies underpin the sBLA for Dupixent. These trials evaluated Dupixent’s efficacy and safety in adults with uncontrolled COPD who were current or former smokers and had type 2 inflammation (measured by blood eosinophils ≥300 cells/microliter). Dupixent significantly reduced annualized moderate or severe COPD exacerbations by up to 34% and improved lung function compared to placebo, with sustained results at 52 weeks.

Submissions for Dupixent in COPD are also under review by regulatory authorities worldwide, including the EU and China. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils. The safety and efficacy of Dupixent for COPD have not been fully evaluated by any regulatory authority yet.


About COPD and Type 2 Inflammation

COPD is a progressive respiratory disease that significantly impairs lung function and quality of life, leading to symptoms like persistent cough, excessive mucus production, and shortness of breath. The disease is exacerbated by acute episodes requiring systemic corticosteroid treatment or hospitalization, posing a substantial health and economic burden. Type 2 inflammation, identified by elevated blood eosinophils, is a key factor in COPD progression, and Dupixent’s mechanism targets this inflammation to improve patient outcomes.

Sanofi and Regeneron’s Commitment to COPD

Sanofi and Regeneron are dedicated to transforming COPD treatment by investigating the roles of different inflammation types in disease progression. Their COPD clinical research program includes Dupixent and itepekimab, both of which are potentially first-in-class biologics. Dupixent inhibits IL-4 and IL-13 signaling pathways, while itepekimab targets IL-33, an initiator of broad inflammation in COPD. Itepekimab is currently in phase 3 trials.

Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, known to drive type 2 inflammation. It is not an immunosuppressant. Dupixent has shown significant clinical benefits across multiple indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic spontaneous urticaria. Approved in over 60 countries, more than 850,000 patients globally are treated with Dupixent.

Dupilumab, the active ingredient in Dupixent, is being jointly developed by Sanofi and Regeneron. To date, it has been studied in over 60 clinical trials involving more than 10,000 patients with various chronic diseases driven by type 2 inflammation. Ongoing phase 3 studies are exploring its efficacy in conditions like chronic spontaneous urticaria, chronic pruritus of unknown origin, COPD with type 2 inflammation, and bullous pemphigoid.

Sanofi and Regeneron’s Innovative Biologics for COPD Treatment

Regeneron, a leading biotechnology company, is known for its innovative approaches in developing life-transforming medicines. Their proprietary technologies, such as VelociSuite®, accelerate drug development by producing optimized fully human antibodies and bispecific antibodies. Regeneron’s Genetics Center® leverages data-powered insights to identify new treatment targets. Sanofi, a global healthcare leader, focuses on turning scientific breakthroughs into practical treatments, emphasizing sustainability and social responsibility.

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Sanofi and Regeneron’s commitment to advancing COPD treatment through innovative biologics like Dupixent is evident. The extended FDA review period allows for thorough evaluation, with the aim of bringing effective treatment to patients with uncontrolled COPD characterized by type 2 inflammation. This development aligns with their mission to improve health outcomes and transform patient care.




Resource: Sanofi, May 31, 2024

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