Dupixent® Approved as First Biologic for COPD in U.S.

Dupixent has been approved by the U.S. Food and Drug Administration (FDA) as an add-on maintenance treatment for adults dealing with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. This approval, announced by Regeneron Pharmaceuticals, Inc. and Sanofi, marks the first time a biologic medicine has been approved in the U.S. for this specific patient group.

COPD is a debilitating respiratory condition that leads to significant lung damage and progressive decline in lung function, making routine activities challenging. Symptoms often include persistent cough, excessive mucus production, and shortness of breath, which can severely impact the quality of life, leading to sleep disturbances, anxiety, and depression. Exacerbations of COPD frequently require systemic corticosteroids or antibiotics, adding to the significant health and economic burden of the disease. In the U.S. alone, there are approximately 300,000 adults with inadequately controlled COPD and an eosinophilic phenotype.

The FDA's approval of Dupixent is based on data from two pivotal Phase 3 trials, BOREAS and NOTUS. These trials compared the efficacy and safety of Dupixent to a placebo in adults who were already on maximal standard-of-care inhaled therapy. The trials included 938 patients who were current or former smokers with moderate-to-severe COPD and blood eosinophils ≥300 cells per μL. During the 52-week treatment period, patients received either Dupixent or a placebo every two weeks, in addition to their existing inhaled triple therapy.

The results were significant. In the BOREAS trial, patients treated with Dupixent experienced a 30% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks compared to the placebo group. In the NOTUS trial, this reduction was 34%. Additionally, Dupixent led to improvements in lung function, as measured by post-bronchodilator FEV1, and health-related quality of life, assessed by the St. George’s Respiratory Questionnaire (SGRQ). At week 12, patients in the Dupixent group had numerically greater improvements in post-bronchodilator FEV1 compared to the placebo group, with benefits sustained for 52 weeks.

Safety results were generally consistent with the known safety profile of Dupixent. The most common adverse events in the Dupixent group included viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, and local administration reactions. Cholecystitis was reported in a small percentage of patients.

Dupixent has already demonstrated its potential as a first-in-class medicine for type 2 inflammatory diseases, such as asthma and atopic dermatitis. With this new approval, Dupixent offers new hope for COPD patients who often struggle with daily activities and frequent hospitalizations due to exacerbations. George D. Yancopoulos, co-Chairman of the Board, President, and Chief Scientific Officer at Regeneron and a principal inventor of Dupixent, highlighted the significance of this latest approval, noting that it provides a novel option for COPD patients that has shown an unprecedented ability to reduce exacerbations, improve lung function, and enhance quality of life.

Paul Hudson, CEO of Sanofi, echoed this sentiment, emphasizing that Dupixent's approval paves the way for a new treatment paradigm for COPD, a disease with high unmet medical needs. Dupixent's ability to potentially transform the lives of people suffering from COPD underscores its importance in the field of respiratory medicine.

The FDA's Priority Review of Dupixent, reserved for medicines that represent significant improvements in treating serious conditions, further underscores the importance of this new therapeutic option. Following recent approvals in the EU and China, submissions for Dupixent are currently under review with other regulatory authorities worldwide, including Japan.