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On June 25, the National Medical ProductsAdministration (NMPA) approved Novo Nordisk's marketing application for Semaglutide injectionfor long-term weight management (Chinese Brand name: 诺和盈).

Semaglutideinj.Credit:Network

丨What is semaglutide?

Semaglutide belongs to a class of medications knownas glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1hormone that is released in the gastrointestinal tract in response to eating.One role of GLP-1 is to prompt the body to produce more insulin, which reducesblood glucose (sugar). GLP-1 in higher amounts also interacts with the parts ofthe brain that reduce appetite and signal a feeling of fullness.

There are currently threeFDA-approved semaglutideproducts:
Ozempicinjection and Rybelsustablets are approved to lower blood sugar levels in adults with type 2 diabetesmellitus, in addition to diet and exercise. Ozempic isalso approved to reduce the risk of heart attack, stroke, or death in adultswith type 2 diabetes mellitus and known heart disease.Wegovy injectionis approved to help adults and children aged 12 years and older with obesity orsome adults with excess weight (overweight), who also have weight-relatedmedical problems, to lose weight and keep the weight off, in addition to dietand exercise.

As the world's first and currently onlyweekly glucagon-like peptid-1 receptor agonist (GLP-1RA) formulation forlong-term weight management, Semaglutideweight loss achieves an average weight loss of 17% (16.8kg) and providespatients with multiple health benefits beyond weight loss.

Previously, Semaglutide hadbeen approved for diabetes in China, Chinese brand name: 诺和泰. Beforethis approvalfor weight management, the drug had already been used off-label.Now, the domestic marketing application of Semaglutideinjection for weight management has finally been approved by the State Food andDrug Administration, which means that eligible weight loss groups can obtainthe drug through compliance, which is also expected to further promote theglobal sales of Semaglutide.

The newlyapproved innovative drug will be suitable for obese or overweight patients withan initial BMI of 30kg/m2 or greater or between 27kg/m2 and 30kg/m2 with atleast one weight-related comorbiditis.

As of today, China's obesitypatients still lack effective clinical drug treatment means, and the hugemedical demand needs to be met. The approval of Semaglutideweight loss therapy is expected to open a new pattern of domestic obesitytherapy.

Professor Chen Wei, Department ofClinical Nutrition, Chinese Academy of Medical Sciences & PekingUnion Medical College, said: "In view of the limited clinical status ofdrugs approved for obesity treatment in China over the past 20 years, newmedical weight loss drugs can provide patients with safe, effective andconvenient treatment options, and can help Chinese obese patientsscientifically manage their weight and related disease risks and improve theirquality of life, which has a profound impact on the clinical practice ofobesity and related diseases."

Reference:

1. China Business Network

2.https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss

Original author: TropicalFishEnglishChina Food & Drug Administration Magazine Minglish Zhujiangshuichang

Source: WeChat Public Platform