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# Yupelri Approved for COPD Maintenance
- URL: https://www.fdaweb.com/yupelri-approved-for-copd-maintenance/
- Published: 2018-11-09T12:00:00.000Z
- Updated: 2026-09-15T00:43:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142789

FDA has approved a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The long-acting muscarinic antagonist is the first once-daily, nebulized bronchodilator approved for treating COPD, according to the companies.

  
Approval was based on data from two replicate pivotal Phase 3 efficacy studies, which 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, the companies said. Adverse event rates for Yupelri were comparable to placebo, and there were no clinically meaningful differences in blood parameters or electrocardiogram data across all treatment groups, they said.