Mylan, Theravance Biopharma Partner to Submit NDA

Theravance Biopharma, Inc. and Mylan have partnered to submit a New Drug Application to the U.S. Food and Drug Administration for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist. The drug is a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease.

The application is supported by the companies’ Phase 3 program for revefenacin, which consisted of two replicate Phase 3 efficacy studies and a 12-month, open-label, active comparator safety study. In both studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in overall treatment effect on trough FEV1 after 12 weeks of dosing.

“If approved, this product will further strengthen Mylan’s expertise in nebulized respiratory therapies and bolster our commercial presence in the respiratory space. We look forward to our continued work with Theravance Biopharma and the FDA as we progress to final approval.” said Mylan president, Rajiv Malik.