Ildong Pharmaceutical received the approval for its three-compound hypertension complex Twotops Plus (compound: telmisartan/amlodipine/chlorothiazides) from the Ministry of Food and Drug Safety (MFDS)식품의약품안전처.
This is the second Korean incrementally modified complex following Amosartan Plus (compound: losartan/amlodipine/chlortalidon) approved in June.
Ildong일동제약(CEO: Yun Woong-sup윤웅섭) has added diuretic compound hydrochlorothiazides to two-compound complex Twotops (compound: telmisartan/amlodipine) approved last year. The company was given six-year re-examination period by the ministry.
Twotops Plus is the composite treatment of telmisartan and amlodipine with recognized efficacy for treating essential hypertension. There are four types of doses, and people take one dose a day with or without food.
The approval has allowed Ildong to establish the “Twotops family” for hypertension treatment. Especially the company can use differentiated strategy, along with Hanmi Pharm, as the domestic incrementally modified drugs in the three-compound hypertension complex market created by Sevikar HCT.
Twotops Plus is a product that faithfully followed the three-compound hypertension complex formula of ARB+CCB+ diuretic.
Since Daiichi Sankyo Korea한국다이이찌산쿄 released the first three-compound hypertension complex Sevikar HCT (compound: olmesartan/amlodipine/hydrochlorothiazide) in Korea in 2013, the demand for the three-compound hypertension complex based on the formula has steadily increased.
Korean drugmakers, which confirmed high potential demand for composite therapies as more than half of patients with high blood pressure were taking two or more drugs, also turned toward the development of mixed treatments one after another.
Hanmi, Ildong and Yuhan Corp.유한양행 were swifter than others in this particular area. Hanmi and Ildong have completed development and approval processes and are about to release their products.
As Hanmi expects to register drug prices in September, and Ildong hoped to do the same in October, the two will likely stage a fierce competition to preempt the market.
Yuhan Corp. is developing the tentatively named Truset트루셋, by adding chlortalidon to telmisartan/amlodipine. It has been conducting phase 3 clinical trials since getting the regulatory go-ahead in 2015.