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.