The China Mail - China extends Wegovy approval to adults with advanced fatty liver disease

China’s National Medical Products Administration approved Wegovy on Sept. 10 for a severe form of fatty liver disease, making the semaglutide product the country’s first and only GLP-1 medicine authorized for that condition.

The approval applies to adults with metabolic dysfunction-associated steatohepatitis, known as MASH, who have moderate-to-advanced liver damage but not cirrhosis. MASH involves inflammation resulting from excess liver fat; cirrhosis is permanent scarring.

The decision was based on a trial involving 1,197 patients with MASH and moderate-to-advanced liver scarring. About two-thirds of those receiving semaglutide experienced resolution of MASH, while slightly more than one-third had reduced liver scarring.

Fatty liver disease affects approximately one in three adults in China and more than 80% of people with obesity. An estimated 6.7% of Chinese adults have MASH. Some people with that condition may fall outside the eligibility criteria previously used for GLP-1 weight-management treatment.

Jia Jidong, director of Beijing Friendship Hospital’s Liver Research Center, told domestic media that effective medicines for fatty liver disease had been limited, leaving treatment largely reliant on lifestyle changes. He said the approval could also increase awareness of an illness that may cause no noticeable symptoms in its early stages.

A Lancet Commission report on liver cancer published last year projected that MASH would account for 11% of liver cancer cases worldwide by 2050, up from 8%.

Developed initially for diabetes, semaglutide is now also widely used for weight management. It mimics GLP-1, a hormone released after eating, and binds to its receptors to suppress appetite. Danish manufacturer Novo Nordisk markets the medicine as Ozempic for diabetes and, at a higher dose, as Wegovy primarily for weight management. China approved Wegovy for weight management in June 2024.

The expansion comes as obesity medicines become more available internationally and manufacturers seek additional uses to distinguish their products. Other companies are studying GLP-1-based treatments for fatty liver disease as well.

Chinese regulators fast-tracked the approval process for Eli Lilly’s tirzepatide in January. Innovent Biologics has reported reductions in liver fat with mazdutide, its medicine approved in China for weight management last year. These developments form part of wider efforts to extend treatments beyond their original weight-loss indications.

R.Yeung--ThChM