US FDA Grants Fast Track Designation to Jardiance® (Empagliflozin) to Improve Outcomes Following a Heart Attack

September 16, 2020 News /BioValleyBIOON/ --Eli Lilly-Boehringer IngelheimDiabetesThe Alliance recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to the SGLT2 inhibitor antidiabetic drug Jardiance (Chinese brand name: Ouyangjing®; generic name: empagliflozin), for patients who have experienced one acute myocardial infarction (commonly known as a heart attack) (with or withoutDiabetes), prevent hospitalization for heart failure and reduce the risk of death.

In the United States, there are more than 1.5 million heart attacks each year, which is the leading cause of heart failure and is associated with a high risk of death. A heart attack occurs due to reduced blood flow to part of the heart muscle.

Previously,FDAJardiance has been granted two FTDs: (1) In June 2019, to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (CHF). (2) In March 2020, to reduce the risk of progression of renal disease and cardiovascular death in adult patients with chronic kidney disease (CKD).

Fast Track Designation (FTD) aims to accelerate drug development and expedited review for serious diseases, addressing critical areas of unmet medical needs. When an investigational drug receives Fast Track designation, it means that pharmaceutical companies can engage with regulatory authorities during the research and development phase toFDAEngage in more frequent interactions; if the relevant criteria are met after submission of the marketing application, it will be eligible for accelerated approval and priority review, as well as rolling review.

The EMPACT-MI study is evaluating Jardiance in adult patients who have experienced one acute myocardial infarction and have no history of chronic heart failure (with and without type 2Diabetes) impact on all-cause mortality and heart failure hospitalization rates. This randomized Phase 3 clinical trial is being conducted, analyzed, and reported in collaboration with the Duke Clinical Research Institute (DCRI), by Boehringer Ingelheim andEli LillyFunding was provided. EMPACT-MI is part of the EMPOWER clinical program, which is the most extensive and comprehensive clinical program for SGLT2 inhibitors. EMPOWER aims to explore the effects of Jardiance on cardiorenal metabolic diseases.

Mohamed Eid, Vice President of Clinical Development and Medical Affairs for Cardiometabolic and Respiratory Medicine at Boehringer Ingelheim, stated, “Ischemic heart disease (IHD) is the leading cause of death and disability in the United States. Myocardial infarction, or heart attack, is the most lethal acute manifestation of IHD, and there is an urgent need for therapeutic options to help improve outcomes. We look forward to collaborating withFDA“Work closely to explore the potential of Jardiance to improve survival rates and prevent hospitalization due to heart failure in adults who have had a heart attack, through our EMPACT-MI trial.”

Eli Lilly“Jeff Emmick, M.D., Vice President of Product Development, stated: “FDAThe Fast Track designation for Jardiance is an important milestone in addressing the unmet needs of patients with heart disease. We remain committed to serving patients with and without type 2Diabetespatients seeking breakthrough results, including the prevention and treatment of heart failure. We look forward to learning the results of EMPACT-MI, which is expected to be completed in 2023.”

Jardiance (Ouyangjing, empagliflozin) belongs to the class of sodium-glucose cotransporter-2 (SGLT-2) inhibitors. Emerging SGLT-2 inhibitor drugs have been proven to block glucose reabsorption in the kidneys, excreting excess glucose from the body and thereby lowering blood sugar levels. This glucose-lowering effect is independent of β-cell function and insulin resistance.

In addition to its clear glucose-lowering effects, this medication offers additional benefits, including weight loss, blood pressure reduction, and uric acid lowering. Jardiance has a favorable safety profile and can reduce the risk of cardiovascular events in patients with diabetes. It is the first type 2 diabetes drug globally proven by research to lower the risk of cardiovascular death.

Jardiance was approved for marketing in August 2014 for the treatment of patients with type 2 diabetes. In late 2016, Jardiance received further approval to reduce the risk of cardiovascular death in patients with type 2 diabetes and established cardiovascular disease. This approval made Jardiance the first glucose-lowering drug globally approved to reduce the risk of cardiovascular death in patients with type 2 diabetes.

Jardiance is a blockbuster SGLT2 inhibitor antidiabetic drug, currently holding over 50% of the SGLT2 inhibitor market share. In recent years,Eli Lilly- The Boehringer Ingelheim alliance has been committed to developing this drug for the treatment of heart failure and chronic kidney disease.

In China, Jardiance (Ouyangjing) was approved for marketing in September 2017. It can be used as monotherapy, in combination with metformin, or in combination with metformin and sulfonylureas to improve glycemic control in patients with type 2 diabetes. In November 2019, Jardiance (Ouyangjing?) was officially included in the National Reimbursement Drug List. The list officially came into effect nationwide on January 1, 2020. It is believed that as the reimbursement list is implemented across the country, more Chinese patients with diabetes will benefit from this excellent therapeutic drug! (Bioon.com)

Original Source: USFDA grants Fast Track designation to Jardiance® (empagliflozin) to improve outcomes following a heart attack