AstraZeneca Korea said Sidapvia (ingredient: dapagliflozin 10 mg, sitagliptin 100 mg) received approval from the Ministry of Food and Drug Safety on June 30 for the treatment of type 2 diabetes in adults aged 18 years and older.

Sidapvia is a combination of Forxiga (dapagliflozin), the best-selling sodium-glucose cotransporter 2 (SGLT-2) inhibitor in Korea, and sitagliptin, the top-selling dipeptidyl peptidase-4 (DPP-4) inhibitor in Korea.

The drug development began when AstraZeneca and SK chemicals in 2020 signed an agreement to develop and produce a Forxiga combination treatment.

SK chemicals will be responsible for the production and supply of Sidapvia, while AstraZeneca will be responsible for commercialization strategy and execution.

According to the Korean Diabetes Association (KDA) guidelines, SGLT-2 inhibitors and DPP-4 inhibitors work by different mechanisms, and the combination of SGLT-2 inhibitors and DPP-4 inhibitors can be expected to provide greater glycemic (HbA1c) lowering effects than either drug alone.

In addition, previous studies in patients with type 2 diabetes have shown that the combination of dapagliflozin and sitagliptin has a more favorable therapeutic and safety profile compared to monotherapy.

As a combination product, Sidapvia is also expected to improve medication adherence in patients with diabetes, helping to manage diabetes and its complications.

“Sidapvia is a unique product developed and produced in Korea in collaboration with SK chemicals,” said Shim Il, AstraZeneca Korea’s Cardiovascular, Renal and Metabolism business unit director. “With Sidapvia, we hope to help people with diabetes manage their type 2 diabetes more easily and effectively."

According to the KDA 2022 Fact Sheet, only about 25 percent of people with diabetes over the age of 30 reach their target glycemia (HbA1c less than 6.5 percent) despite aggressive diabetes treatment.