Yupelri (revefenacin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved November 2018

Specific Treatments:

maintenance treatment of chronic obstructive pulmonary disease

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General Information

Yupelri (revefenacin) is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.

Yupelri is specifically indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.

Yupelri is supplied as a solution for oral inhalation. The recommended dose is one 175 mcg unit-dose vial administered once daily by nebulizer using a mouthpiece. Yupelri should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor.

Clinical Results

FDA Approval

The FDA approval of Yupelri was based on two replicate, randomized, double-blind, placebo-controlled, parallel-group phase III trials designed to provide pivotal efficacy data for once-daily revefenacin over a dosing period of twelve weeks. The studies enrolled a combined total over 1,250 patients with moderate to very severe COPD and assessed two doses (88 mcg and 175 mcg) of revefenacin inhalation solution or matched placebo administered once daily via a standard jet nebulizer. Both trials met their primary efficacy endpoint, demonstrating statistically significant improvements over placebo in trough forced expiratory volume in one second (FEV1) after 12 weeks of dosing for each of the revefenacin doses studied. The improvements in trough FEV1 compared to placebo for the intent-to-treat population across both studies were 118 mL and 145 mL for 88 mcg and 175 mcg, respectively. In pre-specified pooled analyses, revefenacin produced increases in trough FEV1 in the subgroup (38%) of patients using background long-acting beta agonist (LABA) containing therapies and in the subgroup of patients who were not using concomitant LABA therapy. The improvements in FEV1 for the LABA subgroup were 92 mL and 135 mL for 88 mcg and 175 mcg, respectively, and for the non-LABA subgroup were 131 mL and 150 mL for 88 mcg and 175 mcg, respectively.

Side Effects

Adverse effects associated with the use of Yupelri may include, but are not limited to, the following:

cough

nasopharyngitis

upper respiratory tract infection

headache

back pain

Mechanism of Action

Yupelri (revefenacin) is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.

Additional Information

For additional information regarding Yupelri or chronic obstructive pulmonary disease, please visit http://www.yupelri.com/