LG Chem said it has won approval from the Ministry of Food and Drug Safety on Wednesday to go ahead with a phase-1 clinical trial on “EV-81,” an investigational drug combining three agents to treat hypertension and dyslipidemia.
The study will be on 42 healthy males at Seoul National University Hospital, checking the safety, tolerability, and pharmacokinetic interactions of the combination treatment of valsartan (LGEV1801), ezetimibe, and rosuvastatin (LGEV1802). The trials will be randomized and repeated dosing.
The drugmaker said developing a three-in-one combo drug is the first in Korea. LG Chem has been working on other combo drugs as a business strategy.
Besides Rovatitan, a mix of rosuvastatin and valsartan, the company had developed Zemimet, a combo of type-2 diabetes treatment Zemiglo (ingredient: gemigliptin) and metformin. In 2017, the company released Zemiro, a combo of DPP-4 (dipeptidyl peptidase-4) and dyslipidemia remedy rosuvastatin.
Zemiglo, in particular, sold more than 70 billion won ($65.3 million) last year and became a successful local drug competing against novel medicines by multinational firms in the antidiabetic drug market.
The combo of ezetimibe and rosuvastatin is so popular that many drugmakers are selling it under various brands. They include Hanmi Pharmaceutical’s Rosuzet, Yuhan Corp.’s Rosuvamibe, CJ HealthCare’s Rovazet, and Daewoong Pharmaceutical’s Crezet.
Rosuzet sold 38.6 billion won in 2017, Rosuvamibe, 21.2 billion won, and Rovazet, 11.5 billion won. Crezet is expected to sell more than 10 billion won this year, observers said.
LG Chem’s focus on the combo of the three ingredients stemmed from Zemiglo’s success and enhanced business power in selling endocrine system treatments, industry watchers said. The success of ezetimibe and rosuvastatin combo drug also affected the company’s decision to develop the three-agent combo, they added.