EC Grants License for siRNA Cholesterol-Lowering Treatment

December 11, 2020
Pharmaceutical Technology Editors

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients. Novartis announced the news in a Dec. 11, 2020 press release.

Inclisiran is a first-in-class small interfering RNA (siRNA) treatment that aids in the reduction of low-density lipoprotein (LDL) cholesterol. Administered as a single injection initially, then at three months and six month intervals, inclisiran is indicated as an adjunct to diet, in combination with a statin, or statin with other lipid-lowering therapies for patients not reaching their LDL cholesterol target with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant or for whom a statin is contraindicated.

The EC based its decision to grant a license for inclisiran on the results of the ORION clinical research program, which assessed the safety, efficacy, and tolerability of the therapy in over 3600 patients. The granting of the European license follows the company’s announcement in early 2020 that the United Kingdom (UK) will initiate a population health model, making inclisiran available through a population-level agreement.

“Inclisiran has shown considerable and significant improvements in the reduction of cholesterol levels, which could really help in our ongoing battle to tackle the growing burden of cardiovascular disease in the UK,” said Kausik Ray, Professor of Public Health, Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust, in the press release. “This new treatment, with a novel mechanism of action, could also help address two major barriers to improving population health. Namely, achieving even lower cholesterol levels for those most at risk, above that of maximally tolerated statins, and the challenge of long-term non-adherence commonly encountered with current treatments, which require frequent dosing.”

“At Novartis, our purpose is to reimagine medicine. I am proud to say that inclisiran, thanks to this licence, could now be part of this journey,” said Chinmay Bhatt, managing director UK, Ireland, and Nordics for Novartis Pharmaceuticals, in the press release. “As the first and only treatment of its kind, inclisiran embodies our commitment to develop innovative therapies that expand the frontiers of cardiovascular medicine.”

Source: Novartis