FDA approves inclisiran, a twice-yearly injection that lowers cholesterol
Novartis has received FDA approval of inclisiran, a new medication designed to lower low-density lipoprotein cholesterol (LDL-C) with just two doses per year.
Inclisiran, sold under the name Leqvio, is given to patients as an initial injection and then a follow-up injection three months later.
“Leqvio is a revolutionary approach to lower LDL-C and creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” Vas Narasimhan, Novartis CEO, said in a prepared statement. “We now have the opportunity, working together with partners, to provide this first-ever approved LDL-C–lowering siRNA-based therapy to tackle atherosclerotic cardiovascular disease (ASCVD) at scale across the United States.”
“People with ASCVD have most likely experienced a heart attack or stroke from high cholesterol, causing a burden on the family and having a negative impact on lives,” added Andrea Baer, executive director of the Mended Hearts, a patient advocacy group. “One of the first steps to improving patients’ health is to manage high cholesterol and we’re encouraged that this new twice-a-year treatment offers a new option.”
Novartis obtained the global rights to develop, manufacture and commercialize inclisiran thanks to an agreement with Alnylam Pharmaceuticals.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.