FDA approves revefenacin (Yupelri) for COPD

The U.S. Food and Drug Administration (FDA) approved revefenacin inhalation solution to be marketed as Yupelri for ongoing treatment of patients with chronic obstructive pulmonary disease (COPD). Yupelri will be marketed by Theravance Biopharma.

Revefenacin is the first once-daily nebulized bronchodilator approved for COPD in the U.S., according to its manufacturer. Revefenacin is a long-acting muscarinic antagonist.

In randomized trials, 3 months of treatment revefenacin produced improvements compared to placebo in forced expiratory volume in one second (FEV1) and in overall treatment effect on FEV1.

There were no significant safety signals and the adverse event profile was comparable to placebo's. A separate yearlong open-label safety study comparing revefenacin to tiotropium showed comparable safety profiles.

Cough, headache, back pain, and upper respiratory infections were the most commonly reported adverse reactions to revefenacin.

FDA advised against administering revefenacin with other anticholinergic drugs should be avoided. Revefenacin can increase active metabolites of certain hepatically metabolized drugs like rifampin and cyclosporine, advising providers check drug interactions before prescribing. Antimuscarinic drugs including revefenacin may exacerbate or precipitate acute narrow-angle glaucoma.