FDA requests more information before approving mipomersen

CAMBRIDGE, Mass., and SAN FRANCISCO Isis Pharmaceuticals and Genzyme recently announced that the Food and Drug Administration has asked for more study data about its cholesterol drug mipomersen, according to the Associated Press.

As a result, the companies have stated that the drug will face at least a one-year delay as they gather the necessary information. The drug candidate is in late-stage development, but the FDA said it will require data from two ongoing preclinical studies testing whether or not mipomersen causes cancer. The companies anticipate filing an application with the FDA in 2010.

Mipomersen is in the last stage of clinical trials as a treatment for a rare genetic disease that causes people to have extremely high cholesterol levels, raising their risk of premature cardiovascular disease and death. There are only about 10,000 people in the world with the most severe form of the disease, which can cause heart attacks even in young children.

The two companies signed a deal back in early January, under which Genzyme paid $150 million to purchase a stake in Isis, who was developing the drug.