European Union approves Sanofi’s Dupixent for treating lung conditions in smokers, reports ET HealthWorld

Sanofi and Regeneron have received approval from the European Union for the expanded use of their Dupixent injection to treat chronic obstructive pulmonary disease (COPD) in patients who do not respond to standard inhaled drugs. This decision comes after the European Medicines Agency’s recommendation at the end of May. The U.S. Food and Drug Administration, on the other hand, has extended the review deadline for Dupixent in COPD to September 27, citing the need for additional efficacy data.

COPD, also known as ‘smoker’s lungs,’ affects millions of adults in both the United States and Europe, causing airflow restrictions and breathing difficulties. Sanofi anticipates a patient population of approximately 300,000 eligible for Dupixent treatment in the U.S. alone. The drug is already approved for various immune system-related conditions like asthma and eczema in multiple countries.

Sanofi reported 10.7 billion euros in Dupixent revenues in 2023, with expectations of reaching around 13 billion euros this year. The final decision in Europe lies with the European Commission, usually aligned with the EMA’s guidance. The approval highlights a rare case where the EU has cleared a drug for use faster than the U.S., showcasing the importance of addressing critical health needs in a timely manner.