Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a PDUFA target date of November 13, 2018. According to the companies, the agency has said that it is not currently planning to have an advisory committee discuss the NDA.
Theravance Biopharma Chairman and CEO Rick E Winningham commented, “The acceptance of our NDA moves us closer to providing COPD patients with access to once-daily, nebulized LAMA therapy. With positive results in our Phase 3 program, we believe that revefenacin is well positioned to fill this important need. I commend the team at Theravance Biopharma and Mylan for producing a high quality submission, and we look forward to working with the FDA in its review of our application.”
Mylan President Rajiv Malik added, “Today, patients with moderate to severe COPD do not have access to a nebulized LAMA as a treatment option yet. We believe revefenacin, when approved, represents an important advancement in respiratory care by offering a convenient once-daily option for patients, and further strengthens Mylan’s robust and growing respiratory portfolio. We are extremely pleased that the revefenacin NDA has been accepted for FDA review, as it demonstrates the success of our collaboration with Theravance Biopharma, our collective expertise in complex products and the quality of the revefenacin development program.”
Theravance Biopharma and Mylan announced in 2015 that they would partner on development of nebulized TD-4208, with Theravance Biopharma retaining rights to MDI and DPI formulations. Theravance Biopharma also retains the Chinese rights to nebulized revefenacin.
Read the Theravance Biopharma and Mylan press release.
