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The US Food and Drug Administration (FDA) has approved the revefenacin inhalation solution (Yupelri, Theravance Biopharma / Mylan) for the maintenance of patients with chronic obstructive pulmonary disease (COPD).
Revefenacin is a long-acting muscarinic antagonist that is administered once daily at a dose of 175 μg (3 mL) via a standard nebulizer jet. This is the first once-daily nebulised bronchodilator approved for COPD in the United States, the company said in a news release.
Revefanacin must be available at the end of the year.
In two phase 3 efficacy studies, revefenacin showed a statistically significant and clinically significant improvement compared with placebo in forced expiration volume in one second (FEV1) and overall treatment effect on FEV1 trough after 12 weeks of treatment.
The level of side effects (AE) with revefenacin is comparable to those with placebo. There were low levels of serious side effects and no clinically significant differences in blood parameters or electrocardiogram data in all treatment groups (active and placebo).
A 12-month open-label phase safety study comparing revefenacin with tiotropium (Spiriva, Boehringer Ingelheim) doesn't show new security problems. Serious AE and AE levels in this study are low and comparable to those seen in the arm of tiotropium treatment, the company said.
The most common side effects seen with revefenacin include coughing, nasopharyngitis, upper respiratory infections, headaches, and back pain.
Revefenacin should not be used for patients with acute COPD or to treat acute symptoms. Revefenacin must be stopped if paradoxical bronchospasm occurs.
The FDA noted that administration of revefenacin with other drugs containing anticholinergics should be avoided. Also, administration of revefenacin at the same time as OATP1B1 and OATP1B3 inhibitors (for example, rifampicin, cyclosporine, etc.) is not recommended because it can cause increased exposure to active metabolites.
This body also advises patients to be alert to signs and symptoms of acute narrow-angle glaucoma, such as eye pain or discomfort, blurred vision, and visual changes; patients should consult a health care professional immediately if any of these signs or symptoms develop.
Complete prescription information is available online.
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