Theravance Biopharma and Mylan announced that they have initiated Phase 3 studies for TD-4208 revefenacin inhalation solution for the treatment of COPD. The Phase 3 program includes 2 12-week efficacy studies plus a 12-month safety study and is expected to enroll 2,300 patients. The two companies announced in February 2015 that they would partner on development of the nebulized drug, with Theravance Biopharma retaining rights to MDI and DPI formulations.
Theravance Biopharma Senior VP, Clinical Development, Brett Haumann commented, “Despite the fact that once-daily LAMAs are the first-line therapy for patients with moderate-to-severe COPD, there still are no nebulized LAMA treatments available today. This unmet need is significant when one considers that approximately 9% of COPD patients in the US currently use nebulizers for ongoing maintenance therapy, and a total of 41% of US COPD patients use nebulizers for bronchodilator therapy at some time during the course of their disease. Based on data that we’ve generated to date, we believe that revefenacin possesses the product profile that could uniquely and effectively address this market need. We look forward to conducting this Phase 3 program in collaboration with our partner Mylan to generate the data required to support a regulatory filing for the product.”
Mylan President Rajiv Malik said, “The initiation of this Phase 3 program is an important milestone for Mylan as we continue to further build out our global respiratory pipeline. Revefenacin is highly complementary to our currently marketed nebulized COPD product, Perforomist Inhalation Solution, as well as other respiratory products in our pipeline. We are excited by the potential to offer healthcare professionals, and ultimately patients, an even more robust respiratory portfolio if revefenacin is approved. Theravance Biopharma has done an excellent job advancing revefenacin to this stage of development and we look forward to contributing our expertise and leadership in the area of nebulized respiratory therapy as we work together to bring this important product to market.”
Read the Theravance/Mylan press release.
