NEW YORK (AP) — Genzyme Corp. and Isis Pharmaceuticals Inc. said today their cholesterol drug candidate mipomersen met key goals in two late-stage studies.
The companies said mipomersen reduced LDL-C, or total cholesterol, by 36 percent in patients with severe high cholesterol, or hypercholesterolemia, compared with a 13 percent reduction for patients taking placebo. Meanwhile, the drug prompted a 37 percent reduction in total cholesterol for patients with high cholesterol at high cardiovascular risk, compared with 5 percent taking placebo.
Both studies met all their secondary endpoints, and frequently observed side effects included injection site reactions, flu-like symptoms, and elevations in liver enzymes.
The results come months after positive results from a study focusing on patients with a genetic disorder, called heterozygous familial hypercholesterolemia, that raises “bad” cholesterol. At that time in February, the company said it wanted to finish other studies and get the drug on the market before it seeks approval for that illness. One such condition includes homozygous familial hypercholesterolemia, which is rarer than the heterozygous form.
Overall, it has now completed four late-stage studies on the drug for various types of cholesterol conditions. It expects to start seeking Food and Drug Administration approvals during the first half of 2011.
Mipomersen was discovered by Isis, of Carlsbad, Calif., and licensed to Genzyme, which is based in Cambridge, Mass.
