Rosuzet, a dyslipidemia medicine, raised hopes for its maker Hanmi Pharmaceutical of South Korea for greater demand in the outpatient prescription market with additional positive data from a recent study to show superiority to the conventional high-dose statin monotherapy.

During a press conference held in Seoul on Monday, investigators participating in the study (RACING) praised the medicine as a paradigm change in the treatment of dyslipidemia.

Rosuzet launched in Nov. 2015 is a single-pill combination of two different medicines: rosuvastatin (statin), which inhibits cholesterol synthesis in the liver, and ezetimibe, which controls cholesterol absorption in the small intestine.

The drug independently developed by Hanmi Pharm is a leading prescription drug in Korea with over 100 billion won in annual outpatient sales.

Hanmi Pharm expects sales from the drug to surpass 200 billion won ($153 million) in 2024 with additional evidence on treatment benefits from a Rosuzet study was presented in The Lancet in July. The study led by Prof. Kim Byeong-Keuk, a cardiologist at Severance Hospital was conducted in 3,780 patients with arteriosclerotic cardiovascular disease at 26 sites across Korea for five years.

In a randomized three-year follow-up study, the research team compared treatment outcomes between 1,894 patients taking Rosuzet and 1,886 patients using high-intensity statin alone from Feb. 2017 to Dec. 2018. The study findings established evidence that a reduced-dose statin/ezetimibe combination therapy (Rosuzet) is a useful treatment method over the conventional high-dose statin monotherapy, Prof. Kim said.

According to the results, 73 percent in the combo arm reached an endpoint of LDL cholesterol lower than 70mg/dL at one year versus 58 percent in the monotherapy arm. At two and three years, the endpoint was reached in 75 percent and 72 percent of patients in the combo therapy group, respectively versus 60 percent and 58 percent of patients in the monotherapy group.

By Kim Si-gyun and Minu Kim

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