(Reuters) – Sanofi plans to file for U.S. approval of wider use of its anti-inflammatory drug Dupixent against “smoker’s lung”, also known as COPD, after a second large trial showed significant benefits.
Use in COPD, short for chronic obstructive pulmonary disease, could add billions to the French drugmaker’s growth prospects but the trial success also underscores a heavy reliance on its bestselling exzema and asthma drug Dupixent.
Sanofi, which is collaborating on the drug with Regeneron, said in a statement on Monday that a second Dupixent phase 3 COPD trial showed that the drug reduced exacerbations of the disease by 34%.
The findings confirmed positive results from a first trial known as BOREAS earlier this year.
It said on Monday it would file a request for the wider use with the Food and Drug Administration (FDA) by the end of the year. The European Union’s drug regulator is already working on such a request based on the BOREAS data.
Details of the second trial would be presented at an as yet undisclosed medical conference, Sanofi added.
(Reporting by Ludwig Burger; editing by Tassilo Hummel)
