Yupelri Approved to Treat COPD
November 9, 2018 – The U.S. FDA has approved Yupelri™ (revefenacin), manufactured by Theravance and Mylan, to provide maintenance treatment for chronic obstructive pulmonary disease (COPD). It is the first and only nebulized bronchodilator to receive approval to treat COPD in the United States.
COPD affects an estimated 16 million people in the U.S., and is the fourth leading cause of hospital readmissions and a leading cause of death. Bronchodilators treat the disease by relaxing smooth muscle around airways, making it easier for a patient to breathe. Yupelri is a long-acting muscarinic antagonist (LAMA) intended to help keep airways open over time as a maintenance treatment. Unlike short-acting bronchodilators, it is not intended to provide immediate relief from shortness of breath.
In clinical studies, patients treated with Yupelri experienced statistically significant and clinically meaningful improvement compared to patients treated with a placebo, with a low incidence of serious adverse events. Yupelri is administered with a standard jet nebulizer, and offers an alternative treatment option for patients who need a bronchodilator but have difficulty operating an inhaler. The recommended dose is one vial per day.
Yupelri will be available in single-dose 175mcg/3mL vials. Launch and pricing plans have not yet been announced.