Hanmi Pharmaceutical introduced on Dec. 5 that its glucagon-like peptide-1 (GLP-1) weight problems new drug beneath improvement, “Efegletide,” ahas been designated for expedited home product approval assessment by the Ministry of Meals and Drug Security. The corporate plans to use for product approval of Efegletide with the ministry inside this yr, and the launch timing, which was focused for the second half of subsequent yr, is anticipated to be moved up sooner than anticipated.
In accordance with the corporate, the ministry designated Efegletide for International Progressive Quick Monitor (GIFT) assessment on Nov. 27. GIFT was launched by the ministry in September 2022 to help the event of revolutionary medical merchandise in Korea. It’s a system that helps expedited assessment of revolutionary prescription drugs with no current remedy strategies or important potential for medical enchancment, thereby accelerating market launch. To be designated, there should be no current remedy strategies, improved efficacy or security, or it should be a brand new drug developed by an revolutionary pharmaceutical firm.
Efegletide certified for expedited assessment as a brand new drug developed by an revolutionary pharmaceutical firm, and accordingly will obtain advantages for interval discount together with project of a devoted assessment staff and customised assessment course of. In accordance with the ministry, when designated for GIFT, assessment proceeds on a schedule shortened by roughly 25% in comparison with basic assessment durations.
In October, Hanmi Pharm introduced the topline outcomes at week 40 of the core remedy interval of Part 3 medical trials of Efegletide concentrating on 448 grownup overweight sufferers with out diabetes. Knowledge evaluation confirmed weight discount results of as much as 30%, and confirmed favorable security with decrease or gentle gastrointestinal opposed occasion charges in comparison with current GLP-1 preparations, proving differentiated competitiveness. Hanmi Pharm is moreover conducting a 24-week extension examine and plans to judge the sustainability of weight discount results throughout long-term administration over a complete of 64 weeks.
Kim Na-young, head of the New Product Improvement Division at Hanmi Pharm, defined, “When drug uncomfortable side effects are minimal, it improves remedy comfort and remedy continuity, which is advantageous for long-term administration. On this regard, Efegletide has few uncomfortable side effects and may concurrently present built-in administration of metabolic ailments, so it’s anticipated to offer new remedy choices not just for overweight sufferers but in addition for sufferers with excessive diabetes and metabolic threat.”
