The US Food and Drug Administration (FDA) has approved revefenacin inhalation solution (Yupelri, Theravance Biopharma/Mylan) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Revefenacin is a long-acting muscarinic antagonist administered once daily at a dose of 175 μg (3 mL) via a standard jet nebulizer. It is the first once-daily nebulized bronchodilator to be approved for COPD in the United States, the companies said in a news release.
Revefanacin should be available by the end of the year.
In two phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements in comparison to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 after 12 weeks of treatment.
Rates of adverse events (AEs) with revefenacin were comparable to those with placebo. There were low rates of serious adverse events and no clinically meaningful differences in blood parameters or electrocardiogram data across all treatment groups (active and placebo).
A 12-month phase 3 open-label safety study that compared revefenacin to tiotropium (Spiriva, Boehringer Ingelheim) showed no new safety problems. Rates of AEs and serious AEs in the study were low and were comparable to those seen in the tiotropium treatment arm, the companies said.
The most common adverse reactions seen with revefenacin include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain.
Revefenacin should not be used for patients with acutely deteriorating COPD or to treat acute symptoms. Revefenacin should be discontinued if paradoxical bronchospasm occurs.
The FDA notes that administering revefenacin with other anticholinergic-containing drugs should be avoided. Also, administering revefenacin at the same time as OATP1B1 and OATP1B3 inhibitors (eg, rifampicin, cyclosporine, etc) is not recommended because it may cause an increase in exposure of the active metabolite.
The agency also advises patients to be alert for signs and symptoms of acute narrow-angle glaucoma, such as eye pain or discomfort, blurred vision, and visual changes; patients should consult a healthcare professional immediately if any of these signs or symptoms develop.
Full prescribing information is available online.
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Cite this: FDA OKs Revefenacin (Yupelri) for COPD - Medscape - Nov 09, 2018.