Theravance COPD therapy clears pair of Phase III hurdles

Theravance Biopharma Inc. (NASDAQ:TBPH) and Mylan N.V. (NASDAQ:MYL) reported that revefenacin ( TD-4208) met the primary endpoints in two replicate Phase III trials to treat chronic obstructive pulmonary disease. Both of the studies' doses of revefenacin significantly improved trough forced expiratory volume in one second (FEV1) vs. placebo. The trials enrolled a total of more than 1,250 patients with moderate to very severe COPD.

The companies said they are developing the long-acting muscarinic antagonist (LAMA) to be the first once-daily, nebulized bronchodilator for COPD. Theravance expects to complete an ongoing Phase III safety trial next year, and hopes to submit an NDA to FDA by YE17. ...