Chronic Obstructive Pulmonary Disease (COPD) treatment has taken a significant step forward as Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the U.S. Food and Drug Administration (FDA) has extended the target action date for the priority review of The revised target action date is now September 27, 2024. The extension pushes the decision date to September 27, 2024. The sBLA seeks approval for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The FDA has not raised any concerns regarding the approvability of Dupixent for this indication.
The FDA requested additional analyses on the efficacy of Dupixent from the pivotal BOREAS and NOTUS trials. These analyses, submitted earlier in May, were deemed a major amendment to the sBLA, prompting the extension of the review period.
Chronic Obstructive Pulmonary Disease: Regeneron and Sanofi Confident in Dupixent Approval for Type 2 Inflammation
Regeneron and Sanofi remain confident that the additional analyses strongly support the approval of Dupixent for COPD patients with type 2 inflammation. They are committed to collaborating with the FDA to bring Dupixent to patients with uncontrolled COPD as soon as possible.
Beyond the U.S., submissions for Dupixent in COPD are under review by regulatory authorities worldwide, including the European Union (EU) and China. Recently, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils. The potential use of Dupixent in COPD is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
The sBLA is supported by data from the landmark BOREAS and NOTUS Phase 3 trials. These trials evaluated the efficacy and safety of Dupixent in adults who were current or former smokers with uncontrolled COPD and type 2 inflammation (defined as blood eosinophils ≥300 cells per μL). All patients were on background maximal standard-of-care inhaled therapy, nearly all receiving triple therapy.
Both trials met their primary endpoint, showing that Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo. Additionally, Dupixent rapidly and significantly improved lung function, with sustained improvements observed at 52 weeks.
The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Common adverse events (affecting ≥5% of participants) included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Chronic Obstructive Pulmonary Disease: A Progressive Respiratory Disease with Significant Health and Economic Burdens
COPD is a respiratory disease that progressively damages the lungs, leading to a decline in lung function. Symptoms include persistent cough, excessive mucus production, and shortness of breath, which can impair the ability to perform daily activities and may lead to sleep disturbances, anxiety, and depression. COPD is associated with significant health and economic burdens due to recurrent acute exacerbations that often require systemic corticosteroid treatment or hospitalization. Smoking and exposure to noxious particles are primary risk factors, but even individuals who quit smoking can still develop or continue to suffer from COPD. In the U.S., approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation.
Regeneron and Sanofi are dedicated to transforming COPD treatment by exploring the role of different types of inflammation in disease progression. They are investigating two potentially first-in-class biologics: Dupixent and itepekimab.
Dupixent inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), focusing on a specific population with type 2 inflammation. Itepekimab is a fully human monoclonal antibody that inhibits interleukin-33 (IL-33), an initiator of broad inflammation in COPD. Itepekimab is currently under clinical investigation in two Phase 3 trials.
Dupixent, invented using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways and is not an immunosuppressant. Dupixent’s development program has shown significant clinical benefits and a decrease in type 2 inflammation, establishing IL-4 and IL-13 as key drivers of this inflammation in multiple diseases. These diseases include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, and chronic spontaneous urticaria (CSU).
Dupixent has received regulatory approvals for various indications in over 60 countries, including the U.S., Europe, and Japan. Approximately 850,000 patients globally are currently being treated with Dupixent.
Regeneron’s VelocImmune technology utilizes a genetically engineered mouse platform with a humanized immune system to produce optimized fully human antibodies. This technology has been instrumental in creating a significant portion of all original FDA-approved or authorized fully human monoclonal antibodies, including REGEN-COV®, Libtayo®, Praluent®, Kevzara®, Evkeeza®, and Inmazeb®.
In conclusion, the extended FDA review period for Dupixent’s sBLA highlights the thorough evaluation process for this promising treatment. Regeneron and Sanofi remain dedicated to providing new treatment options for COPD patients, aiming to improve the quality of life for those affected by this challenging condition.
Resource: Regeneron, May 31, 2024
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