The Korean Diabetes Association (KDA)’s revised guideline for diabetes treatment is likely to deal a blow to the latecomer SGLT2 inhibitor Steglatro. SGLT2 (sodium-glucose cotransporter 2) inhibitors are a class of drugs that inhibit the reabsorption of glucose in the kidney to lower blood sugar.

Two other SGLT2 inhibitors -- Jardiance (empagliflozin) and Forxiga (dapagliflozin) -- have demonstrated good efficacy in major cardiovascular events (MACE), all-cause death, and heart failure through cardiovascular outcome trials (CVOT). The two medications are likely to achieve robust sale growth on the back of the latest treatment guideline.

However, the late runner Steglatro (ertugliflozin) will face difficulty in getting the benefit of being an SGLT2 inhibitor class drug because it has yet released any outcome related to cardiovascular benefits.

SGLT2 inhibitors are the most recent anti-diabetic drugs. Compared to conventional oral medications, the new medicines have excellent cardiovascular benefits, low risk of hypoglycemia and weight loss effect. SGLT2 inhibitors are quickly expanding their market share in the diabetes treatment market.

UBIST data shows that domestic sales of SGLT2 inhibitors went up to 63.8 billion won ($53.6 million) in 2018 from 12 billion won in 2015. Market leader Forxiga and its combination drug Xigduo took up about 62 percent of the local market share in 2018.

Forxiga posted 27.5 billion won outpatient prescriptions last year, up 6.7 percent from a year earlier. Xigduo, the combo of dapagliflozin and metformin, recorded 12.1 billion won sales, jumping 138.3 percent on-year.

Jardiance is also recording a rapid sales growth, chasing after Forxiga. Combined revenues of Jardiance and Jardiance Duo surged more than 10 folds to 21.8 billion won in 2018 in just two years after recording 2.1 billion won sales in 2016.

Amid the rivalry between Forxiga and Jardiance, Steglatro arrived in the market late last year.

At the time, a Forxiga study called DECARE-TIMI 58 disclosed the results, prompting industrial watchers to believe that its cardiovascular benefits were equal to those of the SGLT2 inhibitors class. Many predicted that the SGLT2 inhibitors market would be enlarged.

Under such circumstance, MSD Korea chose to release Steglatro in the market by skipping drug price negotiations and accepting the government’s reference pricing.

On Saturday, the KDA released its revised guideline for diabetes which mentioned SGLT2 inhibitors’ cardiovascular benefits. The guideline pinpointed Forxiga and Jardiance only as recommended therapies because the two proved cardiovascular benefits through studies.

According to the Diabetes Treatment Guideline, the KDA recommended first considering SGLT2 inhibitors and GLP-1 receptor agonists when choosing a second-line treatment for high-risk patients with atherosclerotic cardiovascular disease (ASCVD), following the first-line treatment of metformin.

Ko Seung-hyun, a professor at the Endocrinology Department at Catholic University of Korea’s College of Medicine, said the EMPA-REG study on Jardiance and DECLARE research on Forxiga showed excellent efficacy in MACE, all-cause death, and heart failure.

The EMPA-REG study, in particular, included Asians who were 25 percent of the subjects and proved that Jardiance reduced the risk of MACE, cardiovascular-related death, and all-cause death in Asians, he said. The result on Asians was quite similar to that of the entire patient group, he emphasized.

The KDA’s recommendation gave a competitive edge to Forxiga and Jardiance over Steglatro and Suglet among SGLT2 inhibitors.

MSD is working on the VERTIS-CV study on Steglatro’s cardiovascular benefits.