According to Theravance Biopharma and Mylan, the FDA has approved the NDA for Yupelri revefenacin inhalation solution for the treatment of COPD. The NDA was submitted in November 2017, and the FDA accepted the application for review in January 2018.
Positive results from Phase 3 studies of revefenacin inhalation solution for COPD were announced in October 2016 and in July 2017.
Theravance Chairman and CEO Rick E. Winningham commented, “Long-acting muscarinic antagonists are recognized by international COPD treatment guidelines as a cornerstone first-line therapy for COPD, regardless of the severity of disease. To date, however, there have been no once-daily nebulized options available to patients or to prescribers. We believe that Yupelri, discovered and characterized in our laboratories, is well positioned to address this need. With this approval, COPD patients who require or prefer nebulized therapy can access a once-daily nebulized bronchodilator for the first time. This approval, which comes during National COPD Awareness Month, is a testament to the collaborative efforts of the Theravance Biopharma and Mylan teams and their dedication to bringing an important treatment option for adults that suffer from COPD.”
Mylan President Rajiv Malik added, “The approval of Yupelri represents a key milestone in advancing and expanding our scientific expertise regarding respiratory care. Yupelri provides COPD patients with access to a nebulized LAMA therapy that offers consistent 24-hour lung function improvement with the convenience of once-daily dosing delivered through any standard jet nebulizer. We are proud to be part of this important approval and pleased to add Yupelri to Mylan’s expanding portfolio of respiratory therapies. Mylan and Theravance Biopharma’s shared commitment to address an important need in the COPD treatment paradigm has served as the driving force behind the success of the clinical development program and ultimate commercial approval of Yupelri.”
Read the Theravance Biopharma and Mylan press release.
