FDA Approves Once-Daily Nebulized Therapy for Maintenance Treatment of COPD

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. Revefenacin also had comparable rates of adverse events to placebo, low rates of serious adverse events, and no clinically meaningful differences in blood parameters or electrocardiogram data, across all treatment groups. The most common adverse effects associated with revefenacin include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.¹

According to pooled data from the two 12-week efficacy trials, which included 1055 patients, revefenacin reduced rates of COPD exacerbations from 15% to 18% in moderate-to-very-severe COPD for up to 52 weeks when compared with placebo and tiotropium (Spiriva HandiHaler).²

In a 12-month phase 3 safety trial, data showed that the estimated annualization rate of all COPD exacerbations was 0.38 for revefenacin dosed at 175 mcg/day and 0.57 for revefenacin dosed at 88 mcg/day, compared with 0.46 for tiotropium dosed at 18 mcg/day. These results for the 175 mcg/day represent a 17% reduction in COPD exacerbation rates compared with tiotropium.²

Researchers also conducted a review of cardiovascular safety data from 4 clinical studies of revefenacin. According to the data analysis, once-daily revefenacin dosed for up to 52 weeks did not prolong QT interval or increase risk of major adverse cardiac events.²

“Yupelri is a welcome new option for the COPD community, including patients and clinicians,” said Sanjay Sethi, MD, professor and chief, pulmonary, critical care, and sleep medicine and assistant vice president for health sciences at the University of Buffalo, in a statement.¹ “With its approval, clinicians will be better able to treat a broad range of COPD patients once-daily, including those who are not able or choose not to use handheld bronchodilators.”

The companies expect revefenacin to be available to patients in the United States before the end of the year, according to the press release.¹

Reference

• Theravance Biopharma and Mylan Receive FDA Approval for YUPELRI™ (revefenacin) in Adults with Chronic Obstructive Pulmonary Disease [news release]. Theravance’s website. https://investor.theravance.com/news-releases/news-release-details/theravance-biopharma-and-mylan-receive-fda-approval-yupelritm. Accessed November 9, 2018.

• Theravance Biopharma and Mylan Report Positive New Data from Multiple Studies of YUPELRI™ (revefenacin) at the 2018 CHEST Annual Meeting [news release]. Theravance’s website. https://investor.theravance.com/news-releases/news-release-details/theravance-biopharma-and-mylan-report-positive-new-data-multiple. Accessed November 9, 2018.