REGULATORY NEWSGenzyme, Isis submit application to EMA for...

REGULATORY NEWS
Genzyme, Isis submit application to EMA for mipomersen
Genzyme has submitted a marketing authorization application to the European Medicines Agency (EMA) in hopes to gain approval for its 200 mg weekly dose of mipomersen, an apo-B synthesis inhibitor indicated to treat hypercholesterolemia and lower LDL cholesterol levels, which is co-developed with Isis Pharmaceuticals.

The Cambridge, Mass.-based Genzyme, a Sanofi company, and Carlsbad, Calif.-based Isis said that if the EMA approves the drug it will be marketed under the brand name Kynamro. The drug reduces LDL-C by preventing atherogenic lipoproteins.

The drug has been evaluated in four Phase III trials where all primary and secondary endpoints were met and the drug lowered LDL cholesterol and reduced other lipids and triglycerides. In fact, a trial presented at ACC.11 showed that mipomersen reduced LDL cholesterol levels by 36 percent in patients with severe heterozygous familiar hypercholesterolemia.

The companies expect to file for U.S. approval in the second half of this year.

T4P...correct

The drug has been evaluated in four Phase III trials where all primary and secondary endpoints were met and the drug lowered LDL cholesterol and reduced other lipids and triglycerides.