CHMP recommends indication extension Leqvio (inclisiran) for hypercholesterolaemia – Novartis

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Leqvio (inclisiran). The marketing authorisation holder for this medicinal product is Novartis Europharm Limited. The CHMP adopted an extension to the existing indication as follows: Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet, and in paediatric patients aged 12 years and older with heterozygous familial hypercholesterolaemia (HeFH) – in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Leqvio (inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (LDL-C). It is a subcutaneous injection given by a healthcare provider (HCP) with an initial dose, another at three months, and then every six months. As a twice-yearly, HCP-administered treatment, Leqvio may help to circumvent the challenges of treatment adherence, a common issue in cholesterol management.