Novartis’ Cholesterol Drug Endorsed by EMA Advisory Group
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the agency issue a marketing authorization for Novartis’ Leqvio (inclisiran) for adult patients with high cholesterol levels who are at risk for cardiovascular disease.
The company is seeking approval for the drug’s use as an adjunct to diet in combination with a statin, or a statin with other lipid‑lowering therapies, for patients who don’t respond to a maximum tolerated dose of a statin.
The marketing authorization would also include the drug’s use alone or in combination with other lipid-lowering therapies in patients who are statin‑intolerant.
Leqvio will be available as a 284-mg solution for injection. The treatment only requires two injections per year and could help 80 percent of high-risk patients in Europe, the company said.
The FDA is also evaluating the drug as an adjunct treatment for high blood cholesterol.