Sanofi-Aventis Korea Tuesday launched dyslipidemia therapy Praluent (ingredient: alirocumab) in Korea.
Praluent inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from binding to low-density lipoprotein receptors (LDLRs). The PCKK9 inhibitor lowers bad cholesterol levels known as LDL-c.
Praluent won approval in Korea in January 2017 and is indicated as an adjunct to diet and maximally tolerated statin therapy to treat adults with familial hypercholesterolemia (either heterozygous or homozygous) or patients with mixed hyperlipidemia along with food.
The therapy will be available as a prefilled pen in 75 mg/mL and 150 mg/mL doses. Patients can self-inject the treatment once every two weeks.
Praluent is currently not reimbursed by the government, although the company said it is about to negotiate with the health authorities.
“We are currently in the midst of negotiations for insurance coverage with the government. We will do our best in our negotiations so that the new therapy Praluent can contribute to the quality of life for high-risk patients,” said Jeremy Grossas, head of Sanofi’s diabetes division.
Sanofi-Aventis said the drug proved efficacy and safety in a global ODYSSEY LONG TERM trial. Patients taking a Praluent combination showed a 62 percent reduction in LDL-C values while 79.3 percent reached the LDL-C goal level of less than 70 mg/dL.
Sub-analysis on Korean patients also showed 92 percent in the Praluent arm achieved the LDL-C treatment goal of less than 70 mg / dL in 24 weeks, Sanofi said.
The most common adverse events were nasopharyngitis, injection site reactions, and influenza. Hypersensitivity reactions such as pruritus, rash, and urticarial and some severe events such as hypersensitivity reactions requiring hospitalization were also reported.