Positive Results for Ph3 Trial of Revefenacin for AECOPD

Patients with moderate to very severe COPD treated with Revefenacin (trade name Yupelri) inhalation solution saw reductions in their rates of acute exacerbation of COPD ranging from 15% to 18% compared to placebo and Spiriva, according to a Phase 3 clinical trial from Theravance and Mylan.

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Revefenacin, designed to be compatible with any standard jet nebulizer, is an investigational LAMA currently under review by the US FDA for the treatment of COPD. If approved, Revefenacin would be the first once-daily, long-acting nebulized bronchodilator for the treatment of COPD.

Pooled data from the two replicate 12-week pivotal Phase 3 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 Revefenacin dosed at 175 mcg/day and 0.45 for Revefenacin 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 3 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 Revefenacin dosed at 175 mcg/day and 0.57 for Revefenacin 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 Revefenacin dose represent a 17% reduction in COPD exacerbation rates as compared to tiotropium.

“While this post-hoc analysis was not powered for statistical significance, it did demonstrate an interesting trend highlighted by a reduction in COPD exacerbation rates,” said lead author James F. Donohue, MD, professor of medicine, pulmonary and critical care medicine at the University of North Carolina, Chapel Hill. “As a clinician, I see firsthand the damaging impact that COPD exacerbations have on patients’ overall health, long-term disease status and quality of life. Results of the analysis are encouraging and provide rationale for further evaluating the impact that Revefenacin may have on reducing COPD exacerbation rate.”