Posted by Michael Wonder on 10 Nov 2018
Theravance Biopharma and Mylan receive FDA approval for Yuperli (revefenacin) in adults with chronic obstructive pulmonary disease
9 November 2018 - Yuperli (revefenacin) is the first and only once-daily, nebulised bronchodilator approved for the treatment of COPD in the US.
Theravance Biopharma and Mylan today announced that the U.S. FDA has approved the new drug application for Yuperli (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Yuperli, a long-acting muscarinic antagonist, is the first and only once-daily, nebulised bronchodilator approved for the treatment of COPD in the US. The companies expect Yuperli to be available to COPD patients in the US before the end of the year.
In two replicate pivotal Phase 3 efficacy studies, Yuperli demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 after 12 weeks of dosing.
