Irbesartan/Amlodipine Besylate

Pharmaceutical companies are trying to strengthen their competitiveness by combining original drug ingredients amid the competition for combination drugs to treat chronic diseases, such as hypertension and diabetes. Handok received approval from the Ministry of Food and Drug Safety for its hypertension combination drug Aprovasc. Aprovasc is Korea's first hypertension combination drug that combines irbesartan and amlodipine. Handok and Sanofi-Aventis Korea jointly developed it. Aprovasc combines irbesartan, a component of Sanofi Aventise’s antihypertensive drug Aprovel, with amlodipine, a calcium channel blocker (CCB). According to Handok, two phase 3 clinical trials demonstrated a superior blood pressure lowering effect compared to irbesartan monotherapy. After collaborating on clinical and licensing activities, Handok and Sanofi-Aventise Korea also plan to collaborate on manufacturing and sales. The companies will co-promote Aprovasc. Handok will be responsible for domestic manufacturing. Handok is also responsible for the domestic manufacturing of Sanofi-Aventise’s Aprovel and Coaprovel. "ARB-series hypertension therapies have been playing an important role in the hypertension market, accounting for the largest share of it," Handok Chairman and CEO Kim Young-jin said. "As Aprovasc is a combination drug that combines irbesartan and amlodipine, in which we have built trust over the years, we expect to see improved adherence and therapeutic effects in hypertensive patients." Suk Sang-kyu, Sanofi Head of Foundation, said, "Aprovasc will provide a new treatment option for patients who cannot attain adequate blood pressure control with monotherapy. We look forward to bringing the benefits of Aprovasc to more patients with hypertension through this partnership and helping them improve their quality of life." In June, SK chemicals received domestic approval for Sidapvia, a diabetes drug co-developed with AstraZeneca. Sidapvia is a combination diabetes treatment that combines the SGLT-2 inhibitor dapagliflozin with the original drug Forxiga and the DPP-4 inhibitor sitagliptin. AstraZeneca supplied SK chemicals with an active pharmaceutical ingredient (API) and invested in research and development costs to develop the combination. "SK chemicals' pharmaceutical technology and production capabilities have been recognized, paving the way for us to supply medicines to more countries," SK chemicals CEO Ahn Jae-hyun said at the time of approval. "We will continue to create various collaboration cases starting with this diabetes combination product."