The Lancet Publishes Paper on New Biologic Developed by Hanmi


A meta-analysis that includes the results of a global clinical trial on efpeglenatide, a new biologic developed by Hanmi, in regard to its safety for the cardiovascular system was published in the October edition of the Lancet, an international medical journal.

Efpeglenatide is a once-weekly GLP-1 receptor agonist developed by Hanmi Pharm for treatment of diabetes mellitus. The recently published paper is based on the Phase 3 clinical trial carried out by Sanofi, which held the right to develop the drug until 2020.

A meta-analysis was conducted by Professor Naveed Sattar from the University of Glasgow in the UK and his team to examine the benefits of the GLP-1 receptor agonist for the cardiovascular system in Type 2 diabetes patients and the hazard ratio. The research team used the clinical data on a total of 60,080 patients from eight GLP-1-related studies conducted with at least 500 subjects that satisfied the selection criteria such as an evaluation of cardiovascular mortality.

This study not only provided additional evidence that GLP-1 receptor agonists, such as efpeglenatide, were safe for the cardiovascular system but also provided support, for the first time, that it reduces the risk of cardiovascular mortality, myocardial infarction, and stroke. The research team even found that GLP-1 receptor agonists reduced the hospitalization rate related to heart failure by 11%, which was statistically significant, and demonstrated the potential of efpeglenatide as a first-in-class drug.

It was also found that once-weekly GLP-1 receptor agonists, like efpeglenatide, produced the same effect as the ones administered on a daily basis.

The paper was written based on the Phase 3 clinical trial on efpeglenatide led by Sanofi that was presented at a scientific session of the American Diabetes Association (ADA) this past June. In the study, 4,076 subjects with either Type 2 diabetes or a cardiovascular disease from 344 regions in 28 countries were administered 4mg or 6mg of efpeglenatide. The results showed that the proportions of the subjects administered the investigational drug who experienced a major cardiovascular event or kidney disease onset were 27% and 32%, respectively, and these numbers were significantly lower than those recorded by the control group (placebo).

Kwon Se-chang, President and co-CEO of Hanmi Pharm, said, “Efpeglenatide, one of the most commonly used GLP-1 receptor agonists in the world, contributed to the encouraging results of the recent meta-analysis. [...] We will do our best to demonstrate the innovative potential of efpeglenatide, which offers benefits in blood glucose and blood pressure regulation and weight loss and has proven safety for the cardiovascular system.”

Source: Metro