Kynamro application submitted

Genzyme and Isis Pharmaceuticals have submitted a marketing authorisation application to the EMA for the approval of Kynamro (mipomersen) to treat homozygous and severe heterozygous familial hypercholesterolemia.

Kynamro is a first-in-class apo-B synthesis inhibitor currently in late-stage development for the reduction of LDL cholesterol (LDL-C).

Paula Soteropoulos, Vice President and General Manager of Genzyme’s Cardiovascular Business, says the submission is a “significant step in the development of mipomersen”.

The US regulatory submission of inhibitor is now planned for later this year.

Familial hypercholesterolemia is a genetic disease that results in increased LDL-C levels and can lead to premature heart disease and heart disease-related death.

Patients with severe familiar hypercholesterolemia have cholesterol levels two-to-four times higher than recommended levels, even when taking multiple cholesterol-lowering medication.

“Mipomersen has the potential to change the management of patients with homozygous and severe heterozygous familial hypercholesterolemia,” said Stanley Crook, Chairman and CEO of Isis Pharmaceuticals.