Innovent’s New Drug Application for Mazdutide in Type 2 Diabetes Receives Acceptance from China’s NMPA
Friday, August 02, 2024
Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company, has announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted its second New Drug Application (NDA) for mazdutide. This dual agonist targets both glucagon-like peptide-1 receptors (GLP-1R) and glucagon receptors (GCGR) and is being evaluated for treating type 2 diabetes (T2D) in adults. Mazdutide is notable as the first GLP-1R/GCGR dual agonist to successfully complete Phase 3 trials for T2D, and its approval could provide a new treatment option for the extensive diabetic population in China, offering benefits in glycemic control, weight loss, and metabolic health.
The NDA submission is based on results from two Phase 3 clinical trials: DREAMS-1, which tests mazdutide as a standalone treatment, and DREAMS-2, which evaluates it alongside oral antidiabetic drugs (OADs). The results indicate that mazdutide is more effective than placebo and dulaglutide 1.5 mg in managing blood glucose levels, reducing weight, and improving various cardiovascular and renal markers. Its safety profile aligns with previous findings and other GLP-1R agonists, with no new safety concerns noted. Detailed results will be shared at upcoming academic conferences or in peer-reviewed journals.
Innovent, expressed optimism about the NDA acceptance, praising the support from regulatory bodies, investigators, and trial participants. He emphasized that mazdutide's effectiveness in lowering glucose and inducing weight loss, along with its cardiovascular and renal benefits, positions it as a significant advancement in T2D treatment in China.
Diabetes is a critical health issue in China, which has the highest number of diabetes cases worldwide, with an estimated 140 million in 2021 and projections of over 174 million by 2045. Managing diabetes effectively is crucial to prevent severe complications like vision loss, kidney dysfunction, and cardiovascular events. As such, there is a strong need for new treatments that not only manage blood glucose but also offer additional benefits such as weight loss and cardiovascular protection.
Mazdutide (IBI362) is being developed through an exclusive licensing agreement with Eli Lilly and Company (Lilly). This mammalian oxyntomodulin (OXM) analogue functions similarly to GLP-1 receptor agonists by promoting insulin secretion, lowering blood glucose, and reducing body weight, while also potentially enhancing energy expenditure and liver fat metabolism through glucagon receptor activation. Clinical trials have shown that mazdutide is effective in weight loss and glucose control, and it provides several additional metabolic benefits.
Source: prnewswire.com
