Mylan, Theravance’s inhaled COPD therapy proves safe in late-stage trial

Mylan (NSDQ:MYL) and Theravance Biopharma, Inc. (NSDQ:TBPH) touted safety data yesterday from the late-stage trial of its once-daily inhaled bronchodilator, revefenacin, in patients with chronic obstructive pulmonary disease.

If approved, revefenacin would be the first nebulized long-acting muscarinic antagonist on the market for COPD patients in the U.S.

Revefenacin was generally well-tolerated among the 1,055 patients who participated in the study and no new safety issues were reported. The data showed low rates of adverse and serious adverse events for both doses of revefenacin compared to Boehringer Ingelheim‘s Spiriva tiotropium therapy.

“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 COPD therapies including combinations of ICS and LABA,” Theravance Biopharma’s chief medical officer, Dr. Brett Haumann, said in prepared remarks. “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.”

“Our revefenacin collaboration with Theravance Biopharma continues to deliver results at every step along the development path,” Mylan president Rajiv Malik added. “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 NDA 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.”

Sunovion Pharmaceuticals is also in the race to develop a nebulized LAMA therapy. Last month, the company submitted a revised new drug application for its eFlow COPD drug-device combo.

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