(Health Korea News / Lee Soon-ho) Daewoong Pharmaceutical has completed clinical trials for its second olmesartan-based triple combination treatment for hypertension and dyslipidemia. As the previously released triple combination drug ‘Olomax Tablet (ingredient name: Olmesartan + Amlodipine + Rosuvastatin)’ has caught up with the prescription amount of the existing two-drug combination drug, attention is being paid to whether the second triple combination drug can also settle in the market.
According to the Ministry of Food and Drug Safety on the 23rd, Daewoong Pharmaceutical recently changed the status of the Phase 3 clinical trial of ‘DWJ1575’ to completed. The final subject observation end date has not been disclosed, but considering that the final subject was selected on July 10th and the drug administration period is 57 days, it is interpreted that the trial was completed at the end of last month or early this month.
Daewoong Pharmaceutical conducted the phase 3 clinical trial of ‘DWJ1575’ first, and received approval for two additional phase 1 clinical trials last year. Since these phase 1 clinical trials were all completed last year, it is expected that the approval process for ‘DWJ1575’ will be able to begin immediately after the data analysis for this phase 3 clinical trial is completed.
‘DWJ1575’ is a triple combination drug that combines olmesartan, an angiotensin II receptor blocker (ARB) class antihypertensive, and rosuvastatin and ezetimibe, representative anti-dyslipidemia treatment components.
Currently, there are three triple combination drugs on the market that combine ARB+statin+ezetimibe: Yuhan-Yanghaeng’s ‘Duowell Plus Tablet’, GC녹십자’s ‘Rozetel Tablet’, and Chong Kun Dang’s ‘Telmirojet Tablet’. Unless Daewoong Pharmaceutical delays its commercialization plan, ‘DWJ1575’ is expected to be the fourth ARB+statin+ezetimibe combination drug in Korea.
In particular, since the three existing products are all combinations of telmisartan, rosuvastatin, and ezetimibe, it appears that the olmesartan-based ‘DWJ1575’ will be able to enter the market by pursuing a strategy of differentiation from these products.
Daewoong Pharmaceutical has four products containing the ingredient olmesartan. The related products are the single drug ‘Olmetec Tablet’, the two-drug combination drug ‘Olostar Tablet (olmesartan + Rosuvastatin)’ and ‘Olmetec Plus Tablet (olmesartan + hydrochlorothiazide)’, and the three-drug combination drug ‘Olomax Tablet (olmesartan + amlodipine + Rosuvastatin)’. Of these, ‘Olmetec Tablet’ has the largest prescription amount at 30 billion won per year.
The remaining ‘Olostar’, ‘Olmetek Plus’, and ‘Olomax’ annual prescription amounts are all maintaining similar levels of around 10 billion won. However, these products are in a state of stagnation in growth. ‘Olmetek’ is at 30 billion won, and the other three products are fluctuating in prescription amounts based on 10 billion won.
Daewoong Pharmaceutical needs a source of energy to overcome this stagnation, and it is predicted that ‘DWJ1575’ will play that role once it is commercialized.
Copyright © Health Korea News. Unauthorized reproduction and redistribution prohibited.
Source: www.hkn24.com
