The FDA has approved revefenacin (Yupelri, Theravance Biopharma, Dublin, Ireland and Mylan, Canonsburg, Pennsylvania) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). A long-acting muscarinic antagonist (LAMA), Yupelri is the first and only once-daily, nebulized bronchodilator approved for COPD in the U.S.
LAMAs are recognized by international COPD treatment guidelines as a key first-line therapy for COPD. Thus far, there have been no once-daily nebulized options for patients. The new approval means that patients who require or prefer nebulized therapy can access a once-daily nebulized bronchodilator for the first time. Revefenacin is compatible with any standard jet nebulizer and provides consistent 24-hour lung function improvement via convenient once-daily dosing.
COPD is the third leading cause of death and the fourth leading cause of hospital readmissions in the U.S. This devasting illness affects approximately 16 million Americans––140,000 of whom die each year––and 65 million people worldwide.
Although smoking is the main cause of COPD, approximately 25% of COPD patients in the U.S. have never smoked. Evidence suggests a link between COPD and other end-stage conditions such as cardiovascular disease (CVD). COPD patients are at increased risk for cardiovascular disease (CVD), and most deaths in COPD are attributed to CVD.
In two replicate pivotal phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo. The most commonly reported adverse events were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.