Sanofi Korea launched Aprovasc Tab, the first antihypertensive combination drug comprising irbesartan and amlodipine besylate co-developed with Handok on Thursday.

Aprovasc won approval from the Ministry of Food and Drug Safety in November 2023 for treating essential hypertension in patients whose blood pressure is not adequately controlled by irbesartan monotherapy.

Arovasc is the result of a collaboration agreement signed in October 2019 between Sanofi and Handok to develop, manufacture, and license antihypertensive combination products in Korea, with Sanofi retaining ownership of the product as the original developer and later partnering with Handok for promotion and product distribution.

Aprovasc is a combination of the angiotensin-receptor blocker (ARB) irbesartan and the calcium channel blocker (CCB) amlodipine and is expected to simplify treatment and provide improved adherence and effective blood pressure control for patients who were previously prescribed separate medications.

Irbesartan has demonstrated potent and competitive systolic blood pressure reduction among the angiotensin-receptor blocker (ARB) class of antihypertensives and is effective in protecting the kidneys and preventing the progression of nephropathy from type-2 diabetes in hypertensive patients with type-2 diabetes and microalbuminuria. Amlodipine, a calcium channel blocker (CCB) class antihypertensive, significantly reduces blood pressure variability and adverse cardiovascular events.

The approval of Arovasc was based on the results of a phase 3 clinical trial study that demonstrated the efficacy and safety profile of Aprovasc in 271 adult essential hypertensive patients 19 and older whose blood pressure was not adequately controlled by irbesartan monotherapy (150 mg in the low dose group and 300 mg in the high dose group).

In the full analysis set (FAS), the LS mean difference in mean systolic blood pressure (msSBP) after eight weeks demonstrated statistically significant blood pressure reductions in both the low and high dose groups compared to irbesartan monotherapy (6.48 mm Hg (-9.94, -3.03) for Aprovasc 150/5 mg, 12.79 mm Hg (-16.26, -9.32) for Aprovasc 150/10 mg, and 7.38 mm Hg (-11.52, -3.24) for Aprovasc 300/5 mg compared to monotherapy).

In both studies, the rates of adverse events (AEs) were not significantly different between treatment and control groups, and no serious adverse drug reactions (SADRs) or AEs resulting in study discontinuation occurred.

"We are excited to expand our irbesartan product portfolio with the launch of an ARB and CCB combination in Korea, following on from our existing Aprovel, Coaprovel, and Rovelito products, and will continue to strive to improve access to treatment for hypertensive patients in Korea," said Suk Sang-kyu, head of Sanofi-Aventis Korea Foundation Business.