Handok, together with the global healthcare company Sanofi’s Korean branch (hereafter referred to as “Sanofi”), has launched the country’s first combination of Irbesartan and Amlodipine in an antihypertensive combination drug called “‘Aprovasc (active ingredients: Irbesartan, Amlodipine)” on February 1st.

Aprovasc, approved by South Korea’s Ministry of Food and Drug Safety on November 28, 2023, is a treatment for essential hypertension when blood pressure is not adequately controlled with Irbesartan alone. Aprovasc was born through a license agreement for the domestic development, manufacturing, and approval of the antihypertensive combination drug signed between Sanofi and Handok in October 2019. Sanofi holds the rights to develop and sell as the original developer, while Handok is responsible for co-promotion with Sanofi and domestic production.

Over 60% of hypertensive patients require the combination of two or more antihypertensive drugs with different mechanisms of action, as a single drug does not control blood pressure adequately. Among these, the combination therapy of Angiotensin Receptor Blockers (ARB) and Calcium Channel Blockers (CCB) is the most commonly used (about 67.8%) in dual therapies.

Aprovasc simplifies treatment strategies by combining the Angiotensin Receptor Blocker Irbesartan and the Calcium Channel Blocker Amlodipine, offering improved drug compliance and efficient blood pressure control for patients previously prescribed each drug separately. Irbesartan has been confirmed to have a powerful and competitive effect in reducing systolic blood pressure among ARB antihypertensive drugs and is effective in protecting kidneys and preventing the progression of nephropathy caused by type 2 diabetes in hypertensive patients with microalbuminuria. Amlodipine, a CCB antihypertensive drug, is known to significantly reduce blood pressure variability and decrease negative cardiovascular events.

The approval of Aprovasc is based on the results of a Phase 3 clinical trial that demonstrated the efficacy and safety profile of Aprovasc in adult patients over 19 years old with essential hypertension whose blood pressure was not adequately controlled with Irbesartan monotherapy (low-dose group 150mg, high-dose group 300mg). The study was conducted in a randomized, double-blind, multi-center, placebo-controlled, parallel design.

The study results showed that Aprovasc had a statistically significant blood pressure-lowering effect in both the low-dose and high-dose groups compared to Irbesartan monotherapy, with reductions in mean systolic blood pressure (msSBP) of 6.48mmHg for Aprovasc 150/5mg, 12.79mmHg for Aprovasc 150/10mg, and 7.4mmHg for Aprovasc 300/5mg.

In both studies, the incidence rate of adverse events (AE) showed no significant difference between the test and control groups, and there were no serious adverse drug reactions (SADR) or adverse events that led to the discontinuation of the clinical trial.