Friday, May 31, 2024
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi have jointly announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a favorable opinion recommending the approval of Dupixent® (dupilumab) in the European Union (EU). This recommendation is specifically for the use of Dupixent as an additional maintenance therapy in adults with uncontrolled chronic obstructive pulmonary disease (COPD) who exhibit elevated blood eosinophils. The final decision from the European Commission is anticipated in the near future.
COPD is a progressive respiratory illness that ranks as the fourth leading cause of death globally. Its symptoms, such as persistent cough, excessive mucus production, and shortness of breath, can severely impact daily activities and may lead to sleep disturbances, anxiety, and depression. COPD also imposes a significant burden on both health systems and economies due to frequent acute exacerbations requiring systemic corticosteroid treatment or hospitalization. While smoking and exposure to harmful particles are primary risk factors for COPD, the disease can persist even after smoking cessation. Notably, there have been no significant advancements in COPD treatment for over a decade.
The positive CHMP opinion is based on data from the BOREAS and NOTUS Phase 3 trials, which assessed the efficacy and safety of Dupixent in adults with uncontrolled COPD and evidence of type 2 inflammation (blood eosinophils ≥300 cells per μL). All participants in these trials were already receiving standard-of-care inhaled therapy, with nearly all on triple therapy. Both trials met their primary endpoint, demonstrating that Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34% compared to placebo. Dupixent also rapidly and significantly improved lung function compared to placebo, with these improvements sustained at 52 weeks. Moreover, Dupixent enhanced health-related quality of life at 52 weeks, as assessed by the St. George’s Respiratory Questionnaire (SGRQ).
Safety findings across both trials were generally consistent with Dupixent's known safety profile in its approved indications. Adverse events more frequently observed with Dupixent (≥5% compared to placebo) included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.
Submissions are currently under review with regulatory authorities globally, including in the U.S. and China. Earlier this year, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD, with a target action date set for September 27, 2024.
The use of Dupixent in COPD remains investigational and has not yet received approval from global regulatory bodies.
Regeneron and Sanofi aim to revolutionize COPD treatment by investigating the role of different inflammation types in disease progression through two potentially groundbreaking biologics: Dupixent and itepekimab.
Dupixent inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, targeting a specific population with evidence of type 2 inflammation. Itepekimab, on the other hand, is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), a trigger and amplifier of widespread inflammation in COPD.
Itepekimab is presently undergoing clinical investigation, with two Phase 3 trials currently enrolling participants. Its safety and efficacy have not yet been assessed by any regulatory authority.
Dupixent, developed using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody inhibiting the IL-4 and IL-13 pathways without acting as an immunosuppressant. Clinical trials within the Dupixent development program have demonstrated significant clinical benefits and a reduction in type 2 inflammation, establishing the pivotal role of IL-4 and IL-13 in various related diseases.
Dupixent has received regulatory approvals in over 60 countries across multiple indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis, and chronic spontaneous urticaria (CSU) across different age groups. Presently, more than 850,000 patients worldwide are benefiting from Dupixent treatment.
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform equipped with a humanized immune system to produce optimized fully human antibodies. The development of this technology traces back to 1985 when Regeneron's co-Founder, President, and Chief Scientific Officer George D. Yancopoulos, alongside his mentor Frederick W. Alt, envisioned creating such a genetically humanized mouse. Regeneron has since dedicated decades to inventing and refining VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have utilized VelocImmune technology to generate a substantial portion of all original, FDA-approved or authorized fully human monoclonal antibodies.
Dupilumab is a collaborative effort between Regeneron and Sanofi, undergoing development across more than 60 clinical trials involving over 10,000 patients with various chronic diseases partly driven by type 2 inflammation.
In addition to its approved indications, Regeneron and Sanofi are investigating dupilumab in Phase 3 trials for a broad range of diseases influenced by type 2 inflammation or other allergic processes, including chronic pruritus of unknown origin, COPD with evidence of type 2 inflammation, and bullous pemphigoid. These potential uses are currently under clinical investigation, with safety and efficacy yet to be fully evaluated by regulatory authorities.
Source: regeneron.com
