Korean regulators have officially recognized the effect of SGLT-2 (sodiumglucose co-transporter 2) inhibitor “Jardiance_자디앙” (compound: empagliflozin) on reducing the risk of side effects in the cardiovascular system, officials said Tuesday. Jardiance became the first -- and only -- case among type 2 diabetes mellitus therapies released here.

The mechanism of SGLT-2 inhibitor involved in the reabsorption of glucose in the kidney is different from conventional diabetes inhibitor. The drug is in the spotlight because it has the additional function to decrease blood sugar and can reduce the weight and blood pressure of diabetes patients. Currently, all three products -- Jardiance, Forxiga_포시가 (compound: dapagliflozin), and Suglat Tab_슈글렛 compound: ipragliflozin) -- are sold in Korea with insurance coverage.

The current market leader is Forxiga made by Astrazeneca Korae_{한국아스트라제네카}, with sales amounting to 24 billion won ($21 million), out of the total SGLT-2 inhibitor market of 27.8 billion won last year. The sales of Jardiance and Suglat stood at only 2 billion won and 1.7 billion won respectively, taking insignificant market shares compared with Forxiga. However, it was only last May that the Ministry of Food and Drug Safety approved Jardiance’s marketing under insurance coverage.

Boehringer Ingelheim Korea, which sells Jardiance says real competition has just started because the ministry has recognized the drug’s effect of reducing the risk of cardiovascular death, which had been considered as the biggest advantage.

According to the EMPA-REG OUTCOME’s study results, Jardiance has reduced the mortality rate by 38 percent for type 2 patients diabetes mellitus with cardiovascular diseases, lowering the death risk by 32 percent related to all diseases, and cutting hospitalization from heart failure by 35 percent. It also decreased total occurrence risk of 3-point MACE, which means death from cardiovascular disease, non-fatal cardiac infarction, and non-fatal stroke, by 14 percent.

Based on these research outcome, the U.S. Food and Drug Administration gave Jardiance the indication about the reduction of mortality rate related to cardiovascular diseases from patients, in December. In March, the European Commission also approved its modification to a drug as the supplement for dietary and workout for type 2 diabetes mellitus patients, and included the reduction of death risks from cardiovascular diseases, in its efficacies.

Experts have emphasized the importance of risk control in the cardiovascular system for the diabetes treatment.

“Because the possible occurrence of cardiovascular diseases for diabetes patients is two to four times higher than patients with other diseases, it is important to comprehensively manage risk factors of cardiovascular diseases as well as blood sugar control for the patients,” said Professor Lim Soo_임수 at endocrinology division of Seoul National University Bundang Hospital_{분당서울대병원}.

Boehringer Ingelheim will promote the drug based on the fact it is the only medicine among diabetes therapies to acknowledge “the effect of reducing the incidents of cardiovascular diseases” from the food and drug safety ministry.

It remains to be seen whether Jardiance can grow to threat Forxiga’s stronghold in the market with high potential, industry watchers say.