A new chronic obstructive pulmonary disease (COPD) drug co-developed by Mylan and Theravance Biopharma has been approved by the FDA. Yupelri is a long-acting muscarinic antagonist (LAMA) which has the advantage of being the first once-daily inhaler for COPD.
“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.”
About 16 million Americans are affected by COPD, a progressively-worsening respiratory disease characterized by symptoms such as breathing problems, coughing and breathlessness. While up to 90 percent of cases are caused by smoking, genetics and exposure to certain chemicals can also account for some cases of 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.”
Since November is COPD Awareness Month, the approval of Yupelri couldn’t have come at a more apt time for Mylan and Theravance. The two companies are aiming to make Yupelri available to US COPD patients by the end of 2018.
“Yupelri is a welcome new option for the COPD community, including patients and clinicians,” said Dr. Sanjay Sethi, 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.”
The FDA approval is the second win for Thervance this month as the pharmaceutical company recently sold its bacterial pneumonia drug, Vibativ, to Cumberland Pharmaceuticals in a deal worth $25 million.