Novartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year

发布时间： 2020-12-15 阅读：695次

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December 11, 2020 — Novartis announced today that the European Commission (EC) has approved Leqvio®* (inclisiran) for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. This approval is based on the results of the robust ORION clinical development program, where Leqvio provided an effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of up to 52% in patients with elevated LDL-C, despite maximally tolerated statin therapy. With two doses a year, after an initial dose and one at 3 months, Leqvio is expected to support long-term adherence.

“Long-term exposure to persistently elevated LDL-C increases the risk of ASCVD, which may lead to a cardiovascular event such as a heart attack or a stroke. As the first and only siRNA providing effective and sustained LDL-C reduction, Leqvio will give an opportunity to change how elevated LDL-C is treated , a highly important modifiable risk factor for ASCVD,” said Professor Ulf Landmesser, M.D., Director of Charité Center for Cardiovascular Diseases, Berlin. “With only two doses a year administered by a healthcare professional, Leqvio is expected to circumvent the challenges of treatment adherence by improving therapeutic coverage and persistence.”

“Cardiovascular disease remains the leading cause of mortality in Europe, which demonstrates the urgent need for innovative treatments for patients struggling to reach their LDL-C goals. With Leqvio, we’re proud to bring a first-in-class treatment delivering effective and sustained LDL-C reduction that has the potential to improve outcomes for people living with ASCVD,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “At Novartis, we’re committed to reimagining care for cardiovascular disease by working together with healthcare systems and other stakeholders to explore innovative access models and bend the curve of life for patients.”