Theravance Biopharma, Mylan get FDA approval for Yupelri

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Theravance Biopharma, Mylan get FDA approval for Yupelri

By Sandra Levy - 11/12/2018
Theravance Biopharma and Mylan have received the green light from the Food and Drug Administration for Yupelri (revefenacin) inhalation solution for the treatment of patients with chronic obstructive pulmonary disease, or COPD.

Yupelri is a long-acting muscarinic antagonist and is the first and only once-daily nebulized bronchodilator approved for the treatment of COPD.

COPD is the third-leading cause of death and the fourth-leading cause of hospital readmissions, 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," Theravance Biopharma chairman and CEO Rick Winningham said. “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."

The companies expect Yupelri to be available before the end of 2018.

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