Regeneron (NASDAQ: REGN), a leading biopharmaceutical company based in the U.S., in collaboration with its French partner Sanofi (NSE: SANOFI), announced on September 27 that Dupixent (dupilumab) has received approvals for the treatment of chronic obstructive pulmonary disorder (COPD) from both the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA). This follows the first global approval for this indication in the European Union in July this year.
The FDA and NMPA have granted approvals for Dupixent to treat inadequately controlled COPD with an eosinophilic phenotype, which is characterized by elevated blood eosinophil levels. In China, the approval is specific to patients already receiving a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or a combination of LABA and LAMA if ICS is not suitable. It is estimated that approximately 300,000 COPD patients in the U.S. are eligible for Dupixent treatment, while China, which has the world’s largest COPD population, accounts for 25% of all COPD patients globally.
These approvals in the U.S. and China were supported by data from two Phase III trials, BOREAS and NOTUS, which showed that Dupixent significantly reduced COPD exacerbations by 30% and 34% compared to placebo, respectively.
Discovered by Regeneron and marketed by Sanofi globally, Dupixent is a monoclonal antibody (mAb) that targets interleukin-4 (IL-4) and interleukin-13 (IL-13). It has been approved in over 60 countries for various indications, including atopic dermatitis, asthma, chronic sinusitis with nasal polyps (CRSwNP), eosinophilic esophagitis (EoE), nodular prurigo, and chronic spontaneous urticaria (CSU). The COPD indication marks Dupixent’s fourth approval in China.- Flcube.com
