Regeneron, Sanofi announce Dupixent approval in China for patients with COPD

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the National Medical Products Administration in China has approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist, or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent for the treatment of COPD has been approved in more than 30 countries worldwide, including the 27 countries in the European Union The approval is based on results from the landmark BOREAS and NOTUS Phase 3 trials, which evaluated the efficacy and safety of Dupixent in adults with uncontrolled COPD with raised blood eosinophils. All patients were on background maximal standard-of-care inhaled therapy. Dupixent significantly reduced COPD exacerbations by 30% and 34% compared to placebo in the BOREAS and NOTUS trials respectively. Dupixent significantly and rapidly improved lung function compared to placebo, with improvements sustained at 52 weeks. Improvements in health-related quality of life compared to placebo were also observed, as assessed by the St. George’s Respiratory Questionnaire. Data from both trials were published in separate manuscripts in The New England Journal of Medicine. Safety results in both trials were generally consistent with the known safety profile of Dupixent in its approved indications. The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. Additional adverse reactions of injection site bruising, injection site induration, injection site rash and injection site dermatitis were reported in the COPD trials. Adverse events more commonly observed with Dupixent compared to placebo in either COPD trial were back pain, COVID-19, diarrhea, headache and nasopharyngitis.