MSD Korea said it has won approval to sell an antidiabetic combination drug Steglujan (ingredient: ertugliflozin/sitagliptin) that mixed Steglatro (ertugliflozin) with Januvia (sitagliptin). Earlier in August, the company obtained the nod for Steglatro, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor.
The Ministry of Food and Drug Safety on Wednesday gave the green light to sell Steglujan.
Treating type-2 diabetes, Steglujan is indicated for patients who had no experience of diabetes treatment and have difficulty in controlling blood glucose with a monotherapy. Patients can use Steglujan with metformin if metformin alone or a combination cannot control blood sugar sufficiently.
Also, patients can use Steglujan+metformin combo if their blood sugar is not controlled by metformin and sitagliptin, which is a DPP-4 (dipeptidyl peptidase 4) inhibitor. If physicians want to replace single-agent combo ertugliflozin+sitagliptin, they can prescribe Steglujan alone. Steglujan can be taken once a day, regardless of meals.
MSD’s SGLT-2 inhibitor is a late runner.
It was 2013 when Korea approved the first SGLT-2 inhibitor, Forxiga (dapagliflozin).
However, as physicians still actively prescribe many SGLT-2 treatments, MSD Korea is likely to use the SGLT-2 inhibitor+Januvia combo to target patients who need blood glucose reduction, weight loss, and blood pressure control.
MSD and Pfizer jointly developed Steglatro and Steglujan, giving Pfizer an option to sell antidiabetic drugs. MSD made a significant contribution to changing the paradigm of diabetes treatment, by developing DPP-4 inhibitor Januvia.
Januvia not only lowers blood glucose levels but has fewer problems with hypoglycemia and weight gain than conventional diabetes therapies. Through many studies including one called Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), Januvia proved cardiovascular safety. Physicians still often prescribe Januvia.
SGLT-2 inhibitors are a new class of drugs, having merits of blood sugar control, weight loss, and cardiovascular risk reduction. However, their mechanism involves releasing sugar through urine, which makes the treatment vulnerable to urinary tract infections. The good news is, SGLT-2 inhibitors benefit patients who urgently need weight control or those who suffer severe abdominal obesity, or patients who need blood pressure control.
Encouraged by such advantages, some doctors prescribe a combo of DPP-4 inhibitor and an SGLT-2 inhibitor. Except for a few cases, the national health insurance does not cover the combo of the two. Also, the insurance coverage on SGLT-2 inhibitors differs depending on the product, confusing doctors.
Despite unfavorable conditions, MSD, AstraZeneca and Boehringer Ingelheim won approval for DPP-4 inhibitor+SGLT-2 inhibitor combos -- Steglujan, Qtern, and Glyxambi, respectively, in Korea. This indicates there are enough local patients who are willing to use the combo treatment.
Recently, the Health Insurance Review and Assessment Service (HIRA) has reportedly requested the Korean Diabetes Association to evaluate how reimbursing DPP-4 inhibitor+SGLT-2 inhibitor combo drugs would affect the government’s financing.
Industry watchers are paying attention to whether the health authorities will allow insurance benefits to the combo therapies and give pharmaceuticals a chance to boost sales of DPP-4 inhibitor+SGLT-2 inhibitor combos.