The FDA has approved revefenacin (Yupelri) 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.
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.