Revefenacin: First Global Approval.

Area of Science:

• Pharmacology
• Pulmonology
• Drug Development

Background:

• Chronic obstructive pulmonary disease (COPD) is a progressive lung disease.
• Current treatments often require multiple daily doses.
• There is a need for convenient, long-acting maintenance therapies for COPD.

Purpose of the Study:

• To summarize the development milestones of revefenacin.
• To highlight the regulatory approval process for a new COPD medication.
• To document the first global approval of a once-daily nebulized bronchodilator.

Main Methods:

• Review of clinical trial data (three Phase III trials).
• Summary of regulatory submission and review process by the US Food and Drug Administration (FDA).
• Documentation of key development and manufacturing achievements.

Main Results:

• Revefenacin demonstrated efficacy and safety in Phase III trials for COPD.
• The US FDA granted marketing authorization in November 2018.
• Revefenacin is the first and only once-daily, nebulized long-acting muscarinic antagonist approved for COPD.

Conclusions:

• Revefenacin represents a significant therapeutic option for COPD patients.
• The development and approval of revefenacin offer a new once-daily treatment choice.
• This milestone provides a novel maintenance therapy for chronic obstructive pulmonary disease.