Once-Daily Nebulized Therapy for COPD Gets FDA Approval – APhA submits compounding comments to FDA. – (866) 348-2889.
Officials with the FDA have approved Theravance Biopharma and Mylan’s revefenacin (Yupelri) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), according to a press release.1
Revefenacin, a long-acting muscarinic antagonist, is the first once-daily, long-acting nebulized bronchodilator for the treatment of COPD, according to Theravance. The treatment is designed to be compatible with any standard jet nebulizer.1
Previously reported phase 3 efficacy studies showed revefenacin demonstrated statistically significant and clinically meaningful improvements compared with placebo in trough forced expiratory volume in 1 second (FEV1) and in overall treatment effect on trough FEV1 after 12 weeks of dosing.