Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
By Sriparna Roy
(Reuters) -The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the companies said on Friday.
The health regulator has cleared the drug's use as an add-on treatment for some adults with inadequately controlled chronic obstructive pulmonary disease (COPD), a condition that progressively damages the lungs and causes restricted airflow.
Sanofi last year recorded a combined 10.72 billion euros ($11.94 billion) in sales for Dupixent, which is already used to treat immune system-related conditions such as asthma and eczema in the U.S. and other countries.
The company has said it expects the target COPD patient population eligible for the drug to be roughly 300,000 patients in the U.S. It has anticipated steeper growth in Dupixent sales in 2025 after the launch for COPD in the country.
Analysts on average expect Dupixent, by far Sanofi's best-selling drug, to generate more than 21 billion euros in revenue in 2030, according to estimates compiled by LSEG. BMO Capital Markets analyst Evan Seigerman in May estimated the drug's peak sales in COPD to reach $2.9 billion in the same year.
COPD, which is the fourth leading cause of death globally, is a lifelong condition that commonly affects cigarette smokers but can also be caused by air pollution and related occupational hazards.
In July, the European Union approved the use of the drug in patients who cannot be helped by standard inhaled treatments for the potentially deadly disease.
In late-stage trials, the drug significantly reduced the moderate or severe exacerbations and also helped to significantly improve lung function, compared to a placebo.
Shares of Regeneron were trading 2.5% higher in morning trade.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar and Sriraj Kalluvila)
