Positive Phase III data for Yupelri to treat COPD exacerbations.- Theravance + Mylan

Theravance Biopharma, Inc. and Mylan N.V. announced that positive new data from the companies' Phase III clinical program for Yupelri (revefenacin) inhalation solution were featured in an oral presentation at the European Respiratory Society (ERS) International Congress 2018, which is being held in Paris, France on September 15-19, 2018. Presented data showed reductions in the rates of chronic obstructive pulmonary disease (COPD) exacerbations ranging from 15% to 18% in moderate to very severe COPD patients administered once-daily Yupelri for up to 52 weeks as compared to placebo and tiotropium (Spiriva HandiHaler).

While the Yupelri Phase III program was not designed or powered to achieve statistical significance on differences in COPD exacerbation rates, researchers were interested in a post-hoc analysis of data from the studies to identify trends in this area.

Researchers evaluated and presented data on COPD exacerbations that were collected from the three clinical trials comprising the Phase III Yupelri program. Pooled data from the two replicate 12-week pivotal Phase III efficacy trials, which included a total of 1,229 patients with moderate to very severe COPD, demonstrated that the mean annualized rate of all COPD exacerbations was 0.47 for Yupelri dosed at 175 mcg/day and 0.45 for Yupelri dosed at 88 mcg/day. When compared to the mean annualized rate of exacerbations for placebo of 0.55, these results represent COPD exacerbation rate reductions in the range of 15% to 18%. Additionally, data from the 12-month Phase III safety trial, which included a total of 1,055 with moderate to very severe COPD, demonstrated that the estimated annualized rate of all COPD exacerbations was 0.38 for Yupelri dosed at 175 mcg/day and 0.57 for Yupelri dosed at 88 mcg/day, compared to 0.46 for tiotropium (Spiriva HandiHaler ) dosed at 18 mcg/day. These results for the 175 mcg/day Yupelri dose represent a 17% reduction in COPD exacerbation rates as compared to tiotropium.