Once-Daily, Nebulized Bronchodilator Approved for COPD Treatment

The Food and Drug Administration (FDA) has approved Yupelri (revefenacin; Theravance and Mylan) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Yupelri is a long-acting muscarinic antagonist (LAMA); bronchodilation following inhalation of revefenacin is predominantly a site-specific effect. The product is intended for once-daily inhalation by a standard jet nebulizer connected to an air compressor. 

Yupelri was evaluated in 2 dose-ranging trials, 2 replicate 12-week, Phase 3 confirmatory trials, and a 52-week safety trial. In the 2 replicate 12-week, Phase 3 placebo-controlled trials (N=1229), patients aged ≥40 years with moderate to very severe COPD were randomized to receive Yupelri 175mcg once daily or placebo. The primary endpoint was change from baseline in trough FEV₁ at day 85. 

Treatment with Yupelri showed significant improvement in lung function vs placebo. In Trial 1, the least square mean change in trough FEV₁ was 127mL and -19mL in the Yupelri and placebo groups, respectively (treatment difference 146, 95% CI, 103.7, 188.8). In Trial 2, the least square mean change in trough FEV₁ was 102mL and -45mL in the Yupelri and placebo groups, respectively (treatment difference 147, 95% CI, 97.0, 197.1). In addition, the peak FEV₁ (within the first 2 hours after dosing) improvement on day 1 vs placebo was 133mL and 129mL in Trials 1 and 2, respectively. 

In Trial 1, the St. Georges Respiratory Questionnaire (SGRQ) responder rate (defined as an improvement in score of ≥4 as threshold) on day 85 was 49% for the Yupelri arm vs 34% for placebo (odds ratio [OR] 2.11, 95% CI 1.14, 3.92). In Trial 2, the SGRQ responder rate was 45% vs 39%, respectively (OR  1.31, 95% CI, 0.72, 2.38). 

The most common adverse events reported with therapy were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. 

Yupelri will be available as 175mcg/3mL solution in unit-dose vials packaged in 30-count cartons. 

For more information call (877) 446-3679 or visit Mylan.com.

This article originally appeared on MPR