Leqvio (inclisiran) is approved by MHLW for familial and non-familial hypercholesterolemia and for patients who are at a high risk of developing cardiovascular events – Novartis

Leqvio (inclisiran), became the first siRNA therapy for dyslipidemia approved in Japan. The drug was approved for familial and non-familial hypercholesterolemia and is intended for patients who are at a high risk of developing cardiovascular events and who also show insufficient responses to or are not suited for treatment with HMG-CoA reductase inhibitors. The drug was also approved for the indication of familial and non-familial hypercholesterolemia.

It will be used in patients who meet both of the following requirements: 1) having a high risk of developing cardiovascular events and 2) showing insufficient responses to or being not suited for treatment with HMG-CoA reductase inhibitors. Optimal use promotion guidelines will be compiled to specify more detailed eligibility criteria for facilities and patients.