FDA Approves Revefenacin, a Once-a-Day Nebulized LAMA, for COPD

The FDA approved revefenacin (Yupelri), the first once daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD).

Revefenacin is a long-acting muscarinic antagonist (LAMA) and was developed by Theravance Biopharma; it will be sold by Mylan and should be available at the end of the year. The companies said COPD is the third leading cause of death and the fourth leading cause of hospital readmissions in the United States, 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," said Rick E Winningham, chairman and chief executive officer of Theravance Biopharma, in a statement. "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."

In 2 replicate pivotal phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV₁) and in overall treatment effect on trough FEV₁ (OTE FEV₁) after 12 weeks of dosing.

The drug had comparable rates of adverse events (AEs) to placebo, low rates of serious adverse events (SAEs), and no clinically meaningful differences in blood parameters or electrocardiogram (ECG) data, across all treatment groups (active and placebo). The most common reported adverse events, across both trials and across all treatment groups, were cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. Additionally, the companies completed a 12-month phase 3 open-label safety study versus tiotropium in which no new safety issues were identified. Rates of AEs and SAEs in the study were low and comparable to those seen in the tiotropium treatment arm.

The drug is delivered through a standard jet nebulizer.