Tarrytown-based Regeneron and its partner on the drug Dupixent, Sanofi, reported today that Dupixent has been approved by the European Commission for use in treating certain adults with uncontrolled COPD, chronic obstructive pulmonary disease.
Regeneron describes COPD as a respiratory disease that damages the lungs and causes progressive lung function decline, and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety and depression.
Regeneron said that trials showed that Dupixent improved lung function and also improved health-related quality of life. It’s estimated that approximately 220,000 adults in the European Union can benefit from the use of Dupixent for their COPD.
The European approval covers patients already on a combination of other drugs. Regeneron said that Dupixent’s use for COPD is being reviewed by other regulatory authorities around the world, including in the U.S., China and Japan.
“The approval of Dupixent for COPD is a long-awaited turning point for those who struggle to breathe even through the simplest of tasks, while also facing the risk of hospitalization, irreversible health decline and feelings of hopelessness,” said George D. Yancopoulos, Regeneron’s board co-chair, president, chief scientific officer and principal inventor of Dupixent. “With this approval, we are proud that Dupixent has the potential to redefine the treatment landscape in yet another disease.”
“Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function,” said Paul Hudson, CEO at Sanofi. “With today’s approval of Dupixent, we can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils (a type of white blood cell). We look forward to working with other regulators around the world as quickly as possible to bring this novel treatment approach to patients in more countries.”
