Swiss drug major Novartis AG (NVS) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of Leqvio (inclisiran) for the treatment of adults with hypercholesterolemia or mixed dyslipidemia.
The CHMP recommended granting inclisiran marketing authorization for the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia.
If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients with hypercholesterolemia or mixed dyslipidemia.
Inclisiran is a potential first-in-class small interfering RNA (siRNA) with a new mechanism of action which delivers effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction for patients with atherosclerotic cardiovascular disease (ASCVD).
ASCVD corresponds to the accumulation of lipids over time mainly low-density lipoprotein cholesterol (LDL-C) in the inner lining of the arteries.
This CHMP opinion is based on results from the ORION clinical research program including Phase III trials, which involved more than 3,600 patients on a maximally tolerated statin dose and assessed the safety, efficacy and tolerability of inclisiran.
Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52%, with two doses per year, after an initial dose and one at 3 months, in adults with ASCVD. Further, the reduction in LDL-C achieved with inclisiran was sustained through 17 months, with a safety and tolerability profile similar to placebo.
The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will review the CHMP opinion and is expected to grant a centralized marketing authorization that will be valid in the 27 countries that are members of the EU.
Inclisiran is also under review by the U.S. Food and Drug Administration for the treatment of primary hyperlipidemia (including HeFH) in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy.
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