Up to 30% Weight Loss Achieved
Approval Target Set for Next Year
The GLP-1 (glucagon-like peptide-1) obesity drug "Efeglenatide," developed in-house by Hanmi Pharmaceutical, will undergo expedited review in the domestic approval process.
Hanmi Pharmaceutical announced on December 5 that the Ministry of Food and Drug Safety designated "Efeglenatide," an obesity drug scheduled for approval application within this year, as a candidate for the Global Innovative Product Fast Track (GIFT) program on November 27.
GIFT is a program operated by the Ministry of Food and Drug Safety since September 2022 to support the development of innovative medical products in Korea. The system accelerates the review process for innovative medicines that either lack existing treatments or show significant potential for medical improvement, thereby expediting their market launch.
To be designated as a GIFT candidate, a product must meet certain criteria: ▲ absence of existing treatment options, ▲ significant improvement in efficacy, ▲ improvement in safety, or ▲ development by an innovative pharmaceutical company.
Once designated as a GIFT candidate, the product benefits from various advantages such as assignment of a dedicated review team, customized review, and priority review, which can shorten the approval period. According to the Ministry, GIFT designation reduces the review timeline by approximately 25% compared to the standard process. Efeglenatide qualifies as an "innovative new drug developed by an innovative pharmaceutical company" for the indication of obesity, and has thus been designated for expedited (priority) review.
In October, Hanmi Pharmaceutical announced the topline results at week 40 of the phase 3 core treatment period for Efeglenatide in 448 adult obese patients without diabetes. Data analysis showed up to 30% weight loss, and the drug demonstrated strong competitiveness with a favorable safety profile, as the incidence of gastrointestinal adverse events was either lower or milder than existing GLP-1 agents.
At week 40, the average weight reduction in the Efeglenatide group was 9.75%, showing significant superiority over the placebo group. Notably, in female patients with a BMI under 30 kg/m², an average weight reduction of 12.20% was observed, marking the most prominent effect, with the maximum weight reduction reaching 30.14%.
Secondary endpoints, including BMI, waist circumference, glucose, lipid markers, and blood pressure, also showed significant improvements in the Efeglenatide group compared to placebo, confirming overall metabolic benefits.
Hanmi Pharmaceutical is currently conducting a 24-week extension study to assess the durability of weight loss over a total of 64 weeks of long-term administration. Based on the safety and efficacy results up to week 40, the company plans to submit an approval application within this year.
Kim Nayoung, Executive Vice President and Head of New Product Development at Hanmi Pharmaceutical, stated, "If a drug has fewer side effects, it enhances medication convenience and treatment adherence, making it advantageous for long-term management. Efeglenatide has few side effects and can comprehensively manage metabolic diseases, so we expect it to provide a new treatment option not only for obese patients but also for those with diabetes and high metabolic risk."
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