The US Food and Drug Administration (FDA) has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug's developer, Novartis, announced today.
Credit: Novartis. The approval was based on data from the ORION-9, ORION-10, and ORION-11 trials that evaluated Leqvio in patients 18 years of age and older with HeFH or clinical ASCVD. The Food and ...
The US Food and Drug Administration (FDA) issued a complete response letter regarding Novartis' new drug application (NDA) for inclisiran, a novel treatment for elevated low-density lipoprotein ...
Please provide your email address to receive an email when new articles are posted on . The FDA approved an expanded indication for inclisiran to include patients with high LDL but without a history ...
FRISCO, Texas--(BUSINESS WIRE)--Soleo Health, an innovative leader and national provider of complex specialty pharmacy services, announced today it has been selected as a limited distribution partner ...
More patients with hypercholesterolemia at high/very high risk of cardiovascular (CV) events achieved low-density lipoprotein cholesterol (LDL-C) goals with inclisiran compared with placebo, when ...