Hanmi Pharm Seeks Approval for Triple-Combination Hypertension Drug Amosartan PLUS-L
核心洞察
Hanmi Pharm (搜索) has filed for domestic approval of Amosartan PLUS-L, a triple-combination hypertension (搜索) therapy containing amlodipine, losartan, and chlorthalidone at one-third the standard dose.
Phase 3 clinical trials (HM-APOLLO-301) demonstrated comparable efficacy to standard-dose single agents in adults with mild to moderate hypertension (搜索) over eight weeks.
The low-dose combination therapy showed similar efficacy with improved tolerability, potentially reducing medication-switching rates and enhancing patient convenience.
Hanmi Pharm (搜索) has applied for domestic approval for Amosartan PLUS-L, a novel triple-combination hypertension (搜索) therapy. The drug combines amlodipine, losartan, and chlorthalidone, each at one-third of their standard doses. This application follows the completion of Phase 3 clinical trials, with the therapy poised to become a key growth driver following the success of Hanmi's dual-action dyslipidemia (搜索) drug, Rosuzet (搜索).
According to Hanmi Pharm (搜索), Amosartan PLUS-L integrates three antihypertensive agents with distinct mechanisms of action but at lower doses, making it particularly suitable for patients in the early stages of hypertension (搜索). The company anticipates a potential launch in 2025, aiming to reshape current hypertension treatment strategies.
The efficacy and safety of Amosartan PLUS-L were highlighted at the European Society of Hypertension (搜索) (ESH) conference in Berlin earlier this year, where results from the Phase 3 clinical trial, HM-APOLLO-301, were presented.
HM-APOLLO-301 Trial Details
The HM-APOLLO-301 trial compared the outcomes of an eight-week treatment period using a low-dose triple combination therapy against those of a standard-dose single agent in adult patients with mild to moderate hypertension (搜索). The study demonstrated that the low-dose triple combination achieved comparable efficacy to the standard-dose monotherapy, with no significant differences observed in the incidence of adverse events.
Professor Rhee Moo-yong, a cardiologist at Dongguk University Ilsan Hospital and president of the Korean Society of Hypertension (搜索), commented on the implications of the study during the research presentation: "This study marks a paradigm shift from monotherapy to multi-pathway approaches in early hypertension treatment, improving patient outcomes."
Professor Rhee further emphasized that low-dose combination therapies offer comparable efficacy with enhanced tolerability, which could lead to reduced rates of medication switching and improved patient adherence and convenience.