On April 29, Novo Nordisk issued a press release stating that the National Medical Products Administration (NMPA) has approved Novo Nordisk's research and development and production of Novotel® (Smeglutide Injection) in China for the listing application.
Novotel® (Smeglutide Injection) is a new long-acting glucagon-like peptide-1 (GLP-1) analogue of Novo Nordisk.
It is currently available in the United States, Europe, Canada, and Japan.
Approved for listing in 52 countries and regions.
Novotel® has a half-life of 7 days and is suitable for once a week injection with a stable blood concentration.
The SUSTAIN series of studies have shown that Novotel® can significantly reduce glycated hemoglobin (HbA1c), no matter whether it is used as a single agent or combined with other oral hypoglycemic drugs or basal insulin, with a maximum reduction of 1.
The hypoglycemic effect is significantly better than that of placebo and western medicine.
Gliptin, canagliflozin, dulaglutide, liraglutide, exenatide weekly preparations and insulin glargine and other hypoglycemic drugs.
In clinical studies registered in China, Nuovotai® has an HbA1c compliance rate of 86.
1% in the Chinese population, showing a good hypoglycemic effect.
At the same time, the SUSTAIN 6 study shows that Novotel® can significantly reduce the risk of MACE in patients with type 2 diabetes by 26%, and can significantly improve patients' weight, blood pressure, blood lipids and other indicators, bringing comprehensive benefits for patients with cardiovascular metabolism.
In January 2020, Novotel® cardiovascular indications were approved by the US FDA to reduce the risk of major cardiovascular events in adult patients with type 2 diabetes with cardiovascular disease.