Revefenacin Cuts COPD Exacerbation Rates in Phase 3 Studies

The FDA's Prescription Drug User Fee Act (PDUFA) date for Yupelri (revefenacin) is November 13, 2018
The FDA's Prescription Drug User Fee Act (PDUFA) date for Yupelri (revefenacin) is November 13, 2018

Theravance Biopharma and Mylan announced new data from the Phase 3 program for Yupelri (revefenacin) inhalation solution, an investigational long-acting muscarinic antagonist (LAMA) currently under review for the treatment of moderate to very severe chronic obstructive pulmonary disease (COPD). The findings were presented at the European Respiratory Society (ERS) International Congress 2018.

Pooled data from two identical 12-week pivotal Phase 3 trials (N=1229) in patients with moderate to very severe COPD showed that the mean annualized rate of all COPD exacerbations was 0.47, 0.45, and 0.55 for revefenacin 175mcg/day, 88mcg/day, and placebo, respectively. 

A separate 12-month safety trial (N=1055) of patients with moderate to very severe COPD compared treatment with revefenacin 175mcg/day and 88mcg/day to tiotropium 18mcg/day (Spiriva HandiHaler; Boehringer Ingelheim). The estimated annualized COPD exacerbation rates were 0.38, 0.57, and 0.46 for revefenacin 175mcg/day, 88mcg/day, and tiotropium 18mcg/day, respectively.

"Results of the analysis are encouraging and provide rationale for further evaluating the impact that Yupelri may have on reducing COPD exacerbation rate," said James F. Donohue, MD, University of North Caroline, Chapel Hill, and lead author of the analysis. 

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Previously, the Companies announced data from two 12-month trials which showed that revefenacin produced statistically significant and clinically meaningful improvements in forced expiratory volume (FEV1) compared to placebo after 12 weeks. 

A New Drug Application (NDA) for revefenacin was submitted last year and the FDA has set a Prescription Drug User Fee Act (PDUFA) target date of November 13, 2018. If approved, it would be the first once-daily, long-acting nebulized bronchodilator for the treatment of COPD.

For more information visit ERScongress.org.