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The Medicines Co.'s drug inclisiran reduces cholesterol in late-stage trial

The Medicines Co.'s drug inclisiran reduced cholesterol in patients who received the medicine every six months, meeting the main goals of a phase 3 clinical trial and confirming earlier results.

Inclisiran was tested during a late-stage clinical trial called Orion-11 in 1,617 patients with atherosclerotic cardiovascular disease, which is characterized by the stiffening of blood vessels that carry oxygen and nutrients from the heart to the rest of the body. Other patients in the trial had risks similar to atherosclerotic cardiovascular disease, or had high cholesterol despite receiving the maximum dose of the standard of care statin therapy.

Injections of inclisiran were first administered, then followed with a second injection at three months. Patients then received the medicine every six months throughout the 17 months of the trial.

Parsippany, N.J.-based The Medicines Co. found that inclisiran reduced cholesterol at all checkpoints in the trial. The trial also met its secondary goals, including reducing other lipids and lipoproteins that are risk factors for atherosclerotic cardiovascular disease.

The Medicines Co. said the new results are consistent with safety, efficacy and tolerability seen during earlier phase 1 and 2 clinical trials of inclisiran. Detailed results from the phase 3 trial will be shared during the European Society of Cardiology's ESC Congress 2019 in early September.

The company said that inclisiran will be submitted for regulatory approval in the U.S. in the fourth quarter of 2019, and in Europe in the first quarter of 2020.