When was Ensifentrine officially launched?

Ohtuvayre (Ensifentrine)-Ensefentine inhalation suspension is a new inhalation treatment drug developed by Verona Pharma, a British biopharmaceutical company. Its core active ingredient is RPL-554. This drug entered clinical research in 2015 and was used as a dual-action phosphodiesterase inhibitor to explore the possibility of treating chronic obstructive pulmonary disease (COPD) and asthma. After years of multi-center, controlled clinical trials, exefantine has gradually demonstrated its unique efficacy, safety and good tolerability, and was finally recognized by regulatory agencies.

In June 2024, the U.S. Food and Drug Administration (FDA) officially approved the marketing of exefantine under the trade name "Ohtuvayre" for the treatment of adult patients with COPD as a maintenance treatment. This approval marks it as the first inhaled COPD treatment drug with a PDE3/4 dual inhibitory mechanism, filling the long-standing gap in non-steroidal, dual-target drugs in the treatment of COPD. The FDA's approval was not only based on its good lung function improvement effect in clinical studies, but also because its inhaled dosage form significantly reduced systemic adverse reactions and improved patient compliance.

Although it has been approved in the United States, so far, exefantine has not been officially launched in mainland China, nor has it been included in the national medical insurance directory. If Chinese patients need to use the drug, they must obtain it through overseas drug purchase channels or international patient channels. Since this drug is an innovative drug and is positioned for the maintenance treatment of moderate to severe COPD, if it is successfully applied for marketing in the future, it may have the opportunity to obtain priority review and approval qualifications through the "clinically urgently needed overseas drugs" channel, thus accelerating the marketing process in China.

Reference materials:https://www.drugs.com/monograph/ensifentrine.html