FDA approves Yupelri ( revefenacin )

On November 9, 2018, the FDA approved the new drug Yupelri (Revefenacin) for the treatment of patients with moderate to very severe chronic obstructive pulmonary disease.

Yupelri (Revefenacin) is a nebulizer for long-acting muscarinic antagonists (LAMA). It has a high lung specificity and maintains long-lasting bronchiectasis with only one use per day while preventing systemic side effects of muscarinic antagonists such as dry mouth, constipation, and urinary retention. According to the latest data released on September 18 this year, the therapy can help patients with moderate to very severe chronic obstructive pulmonary disease reduce the risk of deterioration by 15-18%.

Revefenacin is a novel biphenyl carbamate tertiary amine agent that belongs to the family of the long-acting muscarinic antagonists (LABA). The labile primary amide in the structure produces a "soft-drug" site that allows rapid systemic clearance and minimizing of the systemically mediated adverse reactions. The LABA group falls into a parent category known as long-acting inhaled bronchodilators and this type of agents are recommended as a maintenance therapy for chronic obstructive pulmonary disease (COPD).[A40025] From the LABA group, revefenacin is the first once-daily nebulized LAMA treatment.[A40026] It was developed by Theravance Biopharma and FDA approved on November 9, 2018.[L4818]

DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

YUPELRI is a drug for the maintenance treatment of adults with a lung disease called COPD (chronic obstructive pulmonary disease).

How is this drug used?

YUPELRI is a solution used with nebulizer. Patients should use YUPELRI breathing treatment once a day.

What are the benefits of this drug?

YUPELRI relaxes the muscles in the airways. This allows air to move easier in the lungs which helps prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

• Sex: YUPELRI worked similarly in men and women.
• Race: The majority of patients in the trials were White. Differences in how well YUPELRI worked among races could not be determined.
• Age: YUPELRI worked similarly in patients younger and older than 65 years of age.