Revefenacin shows promise in phase 3 trial for treating COPD
A 12-month phase 3 safety study demonstrated positive results of revefenacin for the treatment of chronic obstructive pulmonary disease, according to a press release issued by Theravance Biopharma and Mylan.
Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily, nebulized bronchodilator, according to the release.
“The data from this 12-month safety study build on our observations from the previous three-month efficacy studies and suggest that revefenacin has a favorable safety and tolerability profile when dosed chronically, either as a standalone therapy or when taken as an add-on to other [chronic obstructive pulmonary disease (COPD)] therapies including combinations of [inhaled corticosteroids] and [long-acting beta-agonists (LABA)],” Brett Haumann, MD, chief medical officer at Theravance Biopharma, said in the release. “As of today, there are no approved nebulized LAMAs, despite a significant number of COPD patients needing or preferring nebulized therapy for the treatment of their disease. Having achieved positive efficacy and tolerability data in our Phase 3 program, we and our partner Mylan believe that revefenacin is well positioned to address this important patient need. We remain on schedule to submit the NDA in the fourth quarter of 2017, which is the next step towards our goal of delivering the first once-daily nebulized bronchodilator to the COPD patient community.”
The randomized, active-controlled parallel group trial included 1,055 patients with COPD. Participants received either one of two doses of revefenacin (88 mcg or 175 mcg) that were inhaled once daily via a nebulizer or standard of care (tiotropium [Spiriva]). Other COPD therapies, including LABA or LABA/inhaled corticosteroids were used by half of participants.
Results from the study revealed that revefenacin was generally well-tolerated, with no new safety issues indicated. Compared with patients receiving the standard care treatment, those receiving either dose of revefenacin had lower or comparable rates of both adverse events and serious adverse events. Exacerbations, nasopharyngitis, upper respiratory tract infections and cough were the most frequently reported adverse events. Patients receiving 175 mcg of revefenacin had the lowest rates of COPD exacerbations and those receiving either dose of revefenacin had the lowest frequencies of anti-muscarinic side effects, including dry mouth and constipation.
Previously, Theravance Biopharma and Mylan have reported that revefenacin demonstrated statistically significant and clinically meaningful improvements in moderate to very severe COPD after 12 weeks compared to placebo in two pivotal Phase 3 efficacy studies.
Data from all three studies will support the submission of a new drug application with the FDA, according to the FDA.
“Our revefenacin collaboration with Theravance Biopharma continues to deliver results at every step along the development path,” Rajiv Malik, president of Mylan, said. “We are very pleased with the top-line results from the 12-month safety trial and now feel we have all the data necessary to support a successful [new drug application] filing. Should revefenacin receive approval from the FDA, we look forward to introducing this nebulized LAMA, to ensure the treatment has the greatest possible impact on the lives of patients with COPD.”
Disclosure: Haumann is the chief medical officer at Theravance Biopharma. Malik is the president of Mylan.