Sanofi-Aventis Korea will soon release its diabetes therapy Soliqua in pre-filled pens in Korea, marking it the first Asian launch, company officials said at a press conference in Seoul Thursday.

“Compliance with fixed-dose combination therapy is great in Korea, and many domestic pharmaceutical companies are also investing in fixed ratio co-formulations (FRCs),” said Kim Dol-mi, medical director of Sanofi-Aventis Korea. “Soliqua will serve as a treatment option to restore comfort to those with type 2 diabetes who are concerned with fasting blood sugar, postprandial blood glucose control, and weight gain.”

Kim Dol-mi, medical director at Sanofi-Aventis Korea, speaks at a news conference to launch Soliqua, at the Novotel Ambassador Seoul Gangnam Thursday.

The Soliqua 100/50 (100 units/mL of insulin glargine and 50 mcg/mL of lixisenatide) pre-filled pen will deliver dose steps from 10-40 units of insulin glargine in combination with 5 to 20 mcg lixisenatide, the company said.

Kim noted that the dosage was selected because it best suited Korean patients. The U.S. FDA approved the drug in only a 100/33 ratio to reduce confusion between the 100/50 and 100/33 dosage, Kim added.

The once-daily injection can be administered before a meal to control both post-meal fasting glucose and fasting blood glucose, according to company officials. The patient can set the starting dose, officials said.

“Soliqua can serve as a two-in-one therapy that is not just a combination of two ingredients but a mixture between them that tackles the most critical parts of diabetes care: controlling fasting plasma glucose (FPG) and postprandial plasma glucose (PPG),” Kim said. “Maintenance of both FPG and PPG leads to a good AIC or glycated hemoglobin level.”

Professor Lim Soo from Seoul National University Bundang Hospital’s Department of Internal Medicine also explained the efficacy and safety of Soliqua based on a LixiLan-L study.

“LixiLan-L showed 55 percent of those in the Soliqua arm had lowered glycated hemoglobin levels to less than 7 percent, indicating it met and exceeded the 7 percent set by the American Diabetes Association,” Lim said. “In contrast, only 30 percent in the insulin glargine 100 U/mL-arm had achieved the same.”

The mean HbA1c also fell by almost two-fold (1.1 percent vs. 0.6 percent) while maintaining hypoglycemia risk and lowering the incidence of gastrointestinal adverse events.

“We are pleased to launch Soliqua in Asia with Korea being the first country. We hope that Soliqua will play an important role in changing diabetes patients’ lives for the better,” said Jeremy Grossas, General Manager of Diabetes Cardiovascular.

yjc@docdocdoc.co.kr

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