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ArticleMedicine Guanlan
On the 17th, CDE announced that Enpagliflozin had submitted a new indication listing application in China and was accepted
.
Enpagliflozin is an SGLT2 inhibitor jointly developed by Boehringer Ingelheim and Eli Lilly.
Enpagliflozin is a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that is taken orally once a day
.
In patients with type 2 diabetes with higher blood sugar levels, Enpagliflozin can prevent sugar from being reabsorbed by the kidneys by inhibiting SGLT2, thereby allowing more sugar to be excreted in the urine
In the United States, Empagliflozin has been approved by the FDA for the treatment of multiple indications, including type 2 diabetes, used to reduce the risk of cardiovascular death in adult patients with type 2 diabetes complicated with cardiovascular disease, and used in heart failure with reduced ejection fraction Reduce the risk of cardiovascular death and hospitalization in adult patients with failure
.
A few days ago, the FDA has just granted priority review qualification for the Supplementary New Drug Application (sNDA) of Enpagliflozin to reduce the risk of cardiovascular death and hospitalization in patients with heart failure, regardless of the patient’s left ventricular ejection fraction
In China, Enpagliflozin was first approved in September 2017 to improve blood sugar control in patients with type 2 diabetes
.
In November 2020, Boehringer Ingelheim and Eli Lilly also submitted an application for the marketing of new indications for empagliflozin for the treatment of adult patients with heart failure with reduced ejection fraction in China
On September 30 this year, Eli Lilly issued a press release stating that it had submitted an application to CDE for the registration of new indications for adult patients with heart failure with enpagliflozin for ejection fraction preservation
.
The application is based on the results of a phase 3 clinical trial called EMPEROR-Preserved
The data showed that compared with placebo, in adult patients with heart failure with preserved ejection fraction, empagliflozin reduced the relative risk of cardiovascular death or hospitalization for heart failure by 21%, reaching the primary endpoint of the trial
.
The trial's key secondary endpoint analysis also showed that empagliflozin can also reduce the relative risk of first and second hospitalizations for heart failure by 27%, and significantly delay the decline in renal function
Heart failure is caused by many reasons and is a common and incurable serious chronic disease
.
According to the ejection fraction, heart failure can be roughly divided into two categories: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF)
Reference materials:
[1] Center for Drug Evaluation of China National Medical Products Administration.
[3] Anker et al.
