Hanmi Pharm has applied for domestic approval for Amosartan PLUS-L, a novel triple-combination hypertension 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 drug, Rosuzet.
According to Hanmi Pharm, 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. 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 (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. 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, 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.
