The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023.
REUTERS/Gonzalo Fuentes/File photo Acquire Licensing RightsNov 27 (Reuters) - Sanofi (SASY.PA) plans to seek U.S. approval for it best-selling anti-inflammatory drug Dupixent to be used in the treatment of "smoker's lung", also known as COPD, after a second large trial showed significant benefits.
The company had embarked on a second trial to bolster the statistical reliability of the read-outs.
Details of the second trial would be presented at an as yet undisclosed medical conference, Sanofi added.
The company has been discussing with major watchdogs across the world whether the BOREAS results were substantial enough to support a regulatory review and what role the second trial would play in reviews.
Persons:
Sanofi, Gonzalo Fuentes, BOREAS, Ludwig Burger, Tassilo Hummel, Edwina Gibbs
Organizations:
Sanofi, Polyclonals, REUTERS, Food and Drug Administration, Thomson
Locations:
Lyon, France