File photo: Eli Lilly’s clinical-trial recruitment booth at the Indiana State Fair, July 30, 2023. Photo: Jaireeodell / Wikimedia Commons / CC BY-SA 4.0. Cropped and resized. Adapted image: CC BY-SA 4.0.
Eli Lilly said Thursday that Chinese regulators approved orforglipron for adult weight management, making the once-daily pill the first oral GLP-1 receptor agonist approved for that use in China.
The National Medical Products Administration approved orforglipron calcium tablets, sold in China under the brand name Muyouda, as a Class 1 new drug, according to the company’s announcement. The approval covers adults with obesity, or adults who are overweight and have at least one weight-related condition, alongside a reduced-calorie diet and increased physical activity.
The decision does not include treatment of type 2 diabetes. Lilly said its application for that separate adult indication remains under review by the Chinese regulator.
Orforglipron is a small-molecule, nonpeptide GLP-1 receptor agonist. Lilly said it can be taken once daily at any time without restrictions on food or water, an option for patients who prefer a pill to an injection.
The company said it has completed eight Phase 3 studies of the drug in obesity and type 2 diabetes, involving more than 10,000 patients. Chinese patients took part in six global multicenter studies.
In the ATTAIN-1 obesity study, patients receiving the highest dose who remained on treatment for 72 weeks lost an average of 12.4 kilograms, according to the company’s release. That figure describes patients who stayed on treatment and should not be read as the average outcome for everyone assigned the drug.
Lilly said the most commonly observed adverse events were gastrointestinal, mostly mild to moderate and concentrated during dose increases. Its release did not give a China launch date, price or reimbursement terms.
The company also referenced a previously announced plan to invest up to $3 billion over ten years to expand its Chinese supply chain. That is an earlier investment plan, not a new spending commitment announced with the approval.
Source: Eli Lilly’s China announcement, published November 12.
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