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Revefenacin may be first once-daily, long-acting treatment for COPD


Revefenacin may be first once-daily, long-acting treatment for COPD

Positive results  from Phase 3 clinical program for YUPELRI™(revefenacin) inhalation 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®),announced Theravance Biopharma and Mylan at the European Respiratory Society (ERS) International Congress 2018.

Yupelri (revefenacin) inhalation solution, an investigational long-acting muscarinic antagonist (LAMA) is currently under review for the treatment of moderate to very severe chronic obstructive pulmonary disease.

Researchers evaluated and presented data on chronic obstructive pulmonary disease exacerbations that were collected from the three clinical trials comprising the Phase 3 YUPELRI program.  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 chronic obstructive pulmonary disease 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 3 safety trial, which included a total of 1,055 with moderate to very severe chronic obstructive pulmonary disease , demonstrated that the estimated annualized rate of all chronic obstructive pulmonary disease 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 does represent a 17% reduction in COPD exacerbation rates as compared to tiotropium.

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“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 of more than 15% with the 175 mcg/day YUPELRI dose as compared to both tiotropium and placebo,” said James F. Donohue, lead author for the data presented at ERS.

If approved, reverencing would be the first once-daily, long-acting nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease.

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Vinay Singh

Vinay Singh

Vinay Singh joined Medical Dialogue as Desk Editor in 2018. He covers all the medical specialty news in different medical categories. He also covers the Medical guidelines, Medical Journals, Case Reports as well as all the updates in the medical field. He completed his graduation in Biotechnology from AAIDU and did his MBA from IILM Gurgaon. He can be contacted at editorial@medicaldialogues.in . Contact no. 011-43720751
Source: press release

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    Dr . Saurabh Karmakar September 26, 2018, 12:46 pm

    It has to be seen how it compares with Glycopyrronium , the latest kid on the block. Also head to head trials are needed to compare its efficacy against beta agonist, so that we may get rid of cardiotoxic beta agonist in COPD patients .