Genzyme and Isis Report Results of Two Phase 3 Trials of Mipomersen
Studies Meet Primary Endpoints with 36 and 37 Percent LDL-C Reductions in Severe Hypercholesterolemia and High-Risk Patients
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Genzyme Corp. and Isis Pharmaceuticals Inc. announced results of two phase 3 studies of mipomersen in patients who had high cholesterol levels while on maximally tolerated lipid-lowering therapy. In the study of patients with severe hypercholesterolemia, mipomersen reduced LDL-C, the primary endpoint, by 36 percent compared with a 13 percent increase for placebo. In the study of patients with high cholesterol at high cardiovascular risk, mipomersen reduced LDL-C by 37 percent compared with a 5 percent reduction for placebo. Both studies met all of their secondary endpoints. Frequently observed adverse events were injection site reactions, flu-like symptoms and elevations in liver transaminases, as seen in previous studies.
With these studies, the companies have completed the four phase 3 studies that are planned to be included in the initial U.S. and E.U. regulatory filings for mipomersen. These filings, expected in the first half of 2011, will seek approval for the treatment of patients with homozygous familial hypercholesterolemia (FH), and may also include patients with severe hypercholesterolemia. The two previous phase 3 studies of mipomersen, which focused on patients with homozygous and heterozygous FH, also met their primary and secondary endpoints.
“We are pleased with the robust efficacy of mipomersen across all four phase 3 trials. These data, along with the emerging safety profile, support our focused approach on patients at highest cardiovascular risk who are in the greatest need of new treatments,” said Genzyme Senior Vice President John Butler. “With completion of these studies, we remain on-track with our plans for mipomersen.”
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