The FDA has granted Priority Review to Sanofi and Regeneron’s supplemental Biologics License Application seeking to expand its blockbuster antibody therapeutic Dupixent (dupilumab) into chronic obstructive pulmonary disease, the companies announced Friday.
Tag Archive for: FDA priority reveiw
If approved, the therapy will help the U.S. drugmaker diversify its revenue stream as its blockbuster cancer immunotherapy, Keytruda, moves towards loss of market exclusivity in 2028.