Theravance Biopharma and Mylan have submitted an NDA to the FDA for revefenacin inhalation solution (TD-4208) for the treatment of COPD, the companies said. Theravance and Mylan announced their partnership on the development of nebulized TD-4208 in early 2015.
In October 2016, the companies reported positive results from 2 Phase 3 efficacy studies, with positive results from a Phase 3 safety study announced in July 2017.
Theravance Biopharma Chief Medical Officer Brett Haumann said, “This submission represents a key step in our efforts to bring the first once-daily nebulized LAMA to the COPD patient community. While a significant number of COPD patients require or prefer nebulized therapy, these same patients currently have no access to a nebulized LAMA, broadly considered the cornerstone of COPD maintenance therapy. We are pleased with the comprehensive data package that was generated through our Phase 3 efficacy and safety studies and look forward to the FDA’s review of our NDA.”
Mylan President Rajiv Malik commented, “We are proud of our collaboration with Theravance Biopharma over the past two years on the development of revefenacin and the quality of our NDA submitted to the FDA. If approved, this product will further strengthen Mylan’s expertise in nebulized respiratory therapies and bolster our commercial presence in the respiratory space. We look forward to our continued work with Theravance Biopharma and the FDA as we progress to final approval.”
Read the Theravance Biopharma and Mylan press release.
