CDE accepts CDE's application for the new indication of the "star drug" for the treatment of heart failure, Enpagliflozin

On 18 November, CDE announced that an application for the listing of an imported new drug submitted by Boehringer Ingelheim for the SGLT2 inhibitor Ingley Net Tablet had been accepted by CDE (acceptance number: JXHS2000168).
week, Grigg Ingeham and his partner Eli Lilly and Company just announced that they are submitting a new drug in China for the treatment of adult patients with reduced blood test scores.
screenshot Source: CDE.com Engel net is a daily oral, highly selective sodium glucose co-transport protein 2 (SGLT2) inhibitor.
in people with type 2 diabetes with high blood sugar levels, it inhibits SGLT2 to prevent sugar from being re-absorbed by the kidneys, allowing more sugar to be excreted from the urine.
addition, Ingle net also prevents the re-absorption of salt, thereby increasing the excretion of salt in the body and reducing the fluid load of the body's vascular system.
of sugar, salt, and water in the body induced by engele may help reduce cardiovascular death.
2014, Engele was approved by the U.S. FDA for use in people with type 2 diabetes.
, the new adaptation used to reduce the risk of cardiovascular death in adults with type 2 diabetes associated with cardiovascular disease has again been approved by the FDA, making it the world's first type 2 diabetes drug to reduce the risk of cardiovascular death, as evidenced by a large cardiovascular outcome study.
now, Ingree Net has become a global market for heavy-duty sugar-lowering drugs.
also won the 2018 Prix Galien International Award.
Gallen Award is recognized as the "Nobel Prize in Medicine" and is recognized as the highest honor in the global pharmaceutical and biomedical industries.
In China, Ingreczene was first approved in September 2017 to improve blood sugar control in people with type 2 diabetes through monodrugs, combined metformin or combined metformin and sulfonylurea for diet control and exercise.
is the second adaptation of the drug to be marketed in China.
, it is known that the registration application for Engel net for the treatment of adult patients with reduced shot blood score is based on the EMPEROR-Reduced study in the EMPEROR heart failure study.
this randomized double-blind Phase 3 clinical trial looked at the safety and effectiveness of the use of Engele net in 3,730 patients with chronic heart failure (HFrEF) with reduced blood test scores, whether or not they had diabetes.
July this year, Grigg Ingham and Lilly announced that the phase 3 study had reached its pre-set main destination.
addition of engele net (10 mg) to standard care significantly reduced the compound risk of cardiovascular death or hospitalization due to heart failure (25%) compared to placebo.
and, for patients with or without type 2 diabetes, Engele showed consistent results.
results were published in the New England Journal of Medicine and received widespread attention from the medical community.
heart failure is an aggressive, debilitating and potentially fatal disease, mainly manifested in breathing difficulties, fatigue and fluid retention, affecting the heart and kidney function of patients, seriously reducing the quality of life of patients.
data show that the disease affects more than 60 million people worldwide.
more than 30 years, despite the remarkable results of human research on heart failure treatment, the overall prognosis of the group of heart failure patients was still poor, with higher rates of death and re-hospitalization.
heart failure has huge unseeded clinical needs around the world and there is an urgent need to find new potential therapies.
and Engele is thought to be creating a whole new therapeutic situation in the field of the disease.
an earlier lilly press release, the EMPEROR-Reduced study provides strong evidence that the application of engele net to standard treatment in adult patients with reduced blood test scores reduces the risk of cardiovascular disease and slows the progression of kidney damage.
In addition, in response to a new drug application for heart failure, Grigg Ingeham-Lilly almost achieved Ingley Net's simultaneous submission in China, the United States and the European Union, which was only six days later than in the United States.
also means that Engele Net is expected to bring new treatment options to more heart failure patients in the near future.
addition to this, the two companies are currently exploring further the treatment of engele net for adult heart failure patients with blood test scores retention.