Once-daily revefenacin for COPD in US

January 14, 2019 0 By FM

Revefenacin (Yupelri) has been granted approval as a once-daily, nebulized bronchodilator for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) in the US.

Revefenacin is a long-acting muscarinic antagonist (LAMA).

In two replicate pivotal Phase 3 efficacy studies, revefenacin demonstrated statistically significant improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and an overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing, said Theravance Biopharma, Inc and Mylan N.V.

Additionally, the companies completed a 12-month Phase 3 open-label safety study versus tiotropium in which no new safety issues were identified. Rates of AEs and SAEs in the study were low and comparable to those seen in the tiotropium treatment arm.