July 3 Reuters Sanofi and partner Regeneron on Wednesday won European Union approval for wider use of their Dupixent injection in patients with a chronic lung disease, a rare case of the EU clearing a drug faster than the United States.
The EU Commission approved Dupixent to treat chronic obstructive pulmonary disease COPD in patients that cannot be helped by standard inhaled drugs, Sanofi said in a statement, following a recommendation by the European Medicines Agency EMA at the end of May.
The debilitating disease is also known as 39;smoker39;s lungs39; because in western countries it primarily affects cigarette smokers.
For its part, the U.S. Food and Drug Administration FDA in May pushed back the deadline for reviewing Dupixent in COPD by three months to Sept. 27 as it demanded additional efficacy data.
The potentially deadly disease, which causes restricted airflow and breathing problems, affects nearly 16 million U.S. adults and over 35 million people in Europe, according to government data.
French drugmaker Sanofi said in April it expects the target patient population eligible for the drug to be roughly 300,000 patients in the U.S. alone.
In Europe, the final decision rests with the European Commission, which usually follows EMA39;s guidance.
The drug is already approved in many countries for various immune systemrelated conditions like asthma and eczema.
Sanofi reported 10.7 billion euros in 2023 Dupixent revenues, which includes Regeneron39;s share, and…