Revefenacin: New drug filed with FDA to treat chronic obstructive pulmonary disease

Theravance Biopharma, Inc. and Mylan N.V. announced the submission of a New Drug Application (NDA) to the FDA for revefenacin (TD 4208), an investigational long-acting muscarinic antagonist (LAMA) as a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease (COPD).

The NDA is supported by the companies' Phase III program for revefenacin, which consisted of two replicate pivotal Phase III efficacy studies and a 12-month, open-label, active comparator safety study.

Comment:This submission represents a key step in efforts to bring the first once-daily nebulized LAMA to the COPD patient community. While a significant number of COPD patients require or prefer nebulized therapy, these same patients currently have no access to a nebulized LAMA, broadly considered the cornerstone of COPD maintenance therapy.