CHMP opinion on variation to marketing authorisation for Nilemdo (bempedoic acid).- Daiichi Sankyo.
On 21 March 2024, 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 Nilemdo. The marketing authorisation holder for this medicinal product is Daiichi Sankyo Europe GmbH.
The CHMP adopted a new indication as follows: i. Cardiovascular disease; Nilemdo is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: a. in patients on a maximum tolerated dose of a statin with or without ezetimibe or, b. alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins