FDA accepts NDA from Therevance and Mylan for COPD candidate revefenacin

Theravance Biopharma Inc. (NASDAQ:TBPH) and partner Mylan N.V. (NASDAQ:MYL) said FDA accepted for review an NDA for revefenacin (TD-4208) to treat chronic obstructive pulmonary disease (COPD). The PDUFA date is Nov. 13.

In 2016, the companies reported data from a pair of Phase III trials showing that revefenacin met the primary endpoint of improving trough forced expiratory volume in one second (FEV1) vs. placebo (see BioCentury, Oct. 24, 2016)...