Sanofi-Aventis Korea said Monday its cholesterol-lowering injection Praluent (ingredient: alirocumab) proved “superior efficacy and safety” among Korean patients, with 92 percent of patients achieving LDL-C treatment goals at 24 weeks.
“The sub-analysis of the ODYSSEY KT study showed the safety and LDL-C reduction effect of Praluent to be consistent with global phase 3 clinical trial results,” said Jeremy Grossas, general manager of Sanofi Korea’s diabetes cardiovascular unit. “We are proud to conduct clinical trials for Koreans as part of Sanofi’s efforts to introduce innovative new drugs to the country.”
The sub-analysis of the PCSK9 inhibitor Praluent, co-developed by Sanofi and Regeneron, was presented at the 6th International Congress of Lipid and Atherosclerosis 2017 held in Seoul last month.
The analysis comprised of data from 83 Korean patients whose cholesterol was not adequately controlled despite statin therapy. The study found that the Praluent arm had reduced LDL-C levels of 65.7 percent versus an 11.1 percent increase in the placebo group. 92 percent of patients in the Praluent also had reduced LDL-C levels to less than 70mg/dL compared to 12.7 percent of patients in the placebo arm.
Praluent is the first approved PCSK9 inhibitor in Korea, approved by the Ministry of Food and Drug Safety in January, to treat adult patients with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL cholesterol) or those with atherosclerotic heart problems who need additional lowering of LDL cholesterol.
Although it gained the health authority’s approval this year, it has yet to launch the product in the Korean market. The Korean offshoot of the French pharma giant is still negotiating with health regulators over drug reimbursement, an official said. The second approved PCSK9 inhibitor is Amgen’s Repatha, which was released into the domestic market in August.
The drug is used in combination with statins or other lipid-lowering therapies in patients whose LDL-C is not adequately controlled or in patients with statin intolerance. Praluent is the only PCSK9 inhibitor administered as a subcutaneous injection once every two weeks, the company said.
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