FDA Approves Yupelri

Theravance Biopharma and Mylan announced the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Yupelri, a long-acting muscarinic antagonist (LAMA), is the first and only once-daily, nebulized bronchodilator approved for the treatment of COPD in the US. The companies expect Yupelri to be available to COPD patients in the US before the end of the year. COPD is the third leading cause of death and the fourth leading cause of hospital readmissions in the US, affecting approximately 16 million Americans.

"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," said Rick E Winningham, chairman and chief executive officer of Theravance Biopharma. "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."
"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," said Mylan President Rajiv Malik. "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."

"YUPELRI is a welcome new option for the COPD community, including patients and clinicians," said Sanjay Sethi, M.D., Professor and Chief, Pulmonary, Critical Care and Sleep Medicine and assistant vice president for health sciences at the University of Buffalo. "With its approval, clinicians will be better able to treat a broad range of COPD patients once-daily, including those who are not able or choose not to use handheld bronchodilators."

In two replicate pivotal Phase 3 efficacy studies, Yupelri demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing. Yupelri had comparable rates of adverse events (AEs) to placebo, low rates of serious adverse events (SAEs), and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). Yupelri should not be used in acutely deteriorating COPD or to treat acute symptoms. Yupelri use should be discontinued if paradoxical bronchospasm occurs. As previously reported, the most commonly reported adverse events, across both trials and across all treatment groups, were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Additionally, the companies completed a 12-month Phase 3 open-label safety study versus tiotropium in which no new safety issues were identified. Rates of AEs and SAEs in the study were low and comparable to those seen in the tiotropium treatment arm.

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