Inclisiran by the Medicines Company, USA demonstrated an excellent safety profile and caused the competitors represented by Regeneron and Amgen some anxiety.
The Medicines Company announced new results from a Phase 3 clinical trial of Inclisiran to reduce the low-density lipoprotein cholesterol (LDL “bad” cholesterol)
The drug was evaluated in the patient population (1 561 participants) with atherosclerotic vascular disease and elevated LDL-C. The MedCo proved that the safety profile of Iinclisiran was similar with placebo.
Earlier, the MedCo announced that the trial of Inclisiran had met all efficacy endpoints but released no safety data.
The data came shortly after Regeneron and Amgen cut down prices on two drugs Praluent and Repatha, the blockbusters on the market of the next generation drugs to reduce cholesterol. These are expensive monoclonal antibodies that block the PCSK9 enzyme and dramatically reduce LDL-C level.
The new data definitively confirmed the safety of Inclisiran and gives a chance to the manufacturer to register it in the USA and the EU in the nearest future. According to experts, the approval of Inclisiran by the FDA may transform the cholesterol-lowering drugs market - it is believed that its cost will be lower as compared to the existing PCSK9 inhibitors.
In addition, MedCo’s drug will be more convenient - Inclisiran only needs to be dosed twice a year, far less than the twice-monthly dosing that the monoclonal antibodies employ.