Novartis builds case for Leqvio with monotherapy data

Novartis has a long way to go to make its twice-yearly cholesterol-lowering drug Leqvio the multi-billion-dollar blockbuster it is predicting – but took another step along that road today.

The latest readout from the large-scale VictORION clinical trial programme for Leqvio (inclisiran) – from the V-MONO trial – showed that the drug given on its own was better than placebo or ezetimibe at lowering LDL-cholesterol in patients considered at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD).

The trial recruited patients who were not on lipid-lowering therapy, so a group with a lower risk of developing ASCVD than is currently included on Leqvio's label. Novartis has said it plans to submit the new data to regulators and present the data in full at a future medical congress.

Leqvio was first approved in 2021 as an add-on to statin therapy in patients unable to reach LDL-c on statins alone, on the back of clinical trial data showing it could reduce LDL-cholesterol by up to 52% in patients unable to reach their cholesterol targets, despite taking the maximum tolerable dose of statins.

The drug had its label extended last year to enable earlier use – also in combination – in patients with elevated LDL-c and an increased risk of heart disease due to other conditions like high blood pressure and diabetes.

Novartis said at launch Leqvio was likely to be a slow-growing brand, but it is now showing clear signs of gathered momentum, with sales in the first half of this year rocketing 137% to $333 million.

Leqvio is a small interfering RNA (siRNA) therapy that targets PCSK9, competing with more frequently doses antibody-based therapeutics like Praluent (alirocumab) from Sanofi/Regeneron and Amgen's Repatha (evolocumab), which are given every two or four weeks.

The company said V-MONO is the first trial evaluating an siRNA therapy taken as monotherapy to lower LDL-C in patients at low or moderate risk of developing ASCVD.

"This trial adds to the growing body of evidence for Leqvio across the full spectrum of ASCVD as we strive to help more patients in need," commented Shreeram Aradhye, Novartis' chief medical officer.

The VictORION programme includes several other trials, including outcomes studies looking at Leqvio's potential as primary and secondary prevention of events like cardiovascular death, heart attack, ischaemic stroke, and urgent coronary revascularisation procedures like angioplasty.

Earlier this year, Novartis chief executive Vas Narasimhan said that new clinical readouts for Leqvio – along with take-up of the drug in markets like China, where there is growth as a self-pay treatment even ahead of reimbursement approval – will be the key to reaching "that multi-billion-dollar outlook that we've given" for the drug.