Novartis (NVS) and United Kingdom's National Health Service reached an agreement that will enable broad access to the Swiss drug giant's anti-cholesterol drug Leqvio or inclisiran for hundreds of thousands of high-risk cardiovascular patients.
The deal comes following the positive final recommendation from the National Institute for Health and Care Excellence (NICE) for use of inclisiran in primary care for the treatment of adult patients within its licenced indication who also have persistently elevated LDL cholesterol or LDL-C levels and a history of certain cardiovascular events.
The NICE recommendation was based on results from the Novartis ORION clinical research program, including Phase III trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients and assessed the safety, efficacy and tolerability of inclisiran in lowering LDL-Cholesterol levels.
About 300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisira over three years, Novartis said in a statement.
Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals.
Inclisiran was granted marketing authorization by the European Commission on December 9, 2020.
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