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FDA PROVIDES CLARITY TO ISIS ON MIPOMERSEN REQUIREMENTS.

Publication: Biotech Business
Publication Date: 01-JUN-08 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
Isis Pharmaceuticals, Inc. (NASDAQ:ISIS)and Genzyme Corp. (NASDAQ:GENZ) has announced that the FDA has provided guidance regarding approval requirements for mipomersen. The FDA has indicated that reduction of LDL-cholesterol is an acceptable surrogate endpoint for accelerated approval of mipomersen for use in patients with homozygous familial hypercholesterolemia (hoFH). The FDA will require data from two ongoing preclinical studies for carcinogenicity to be included in the hoFH filing, which is now anticipated to take place in 2010. A phase 3 study of mipomersen in hoFH is currently enrolling patients.

The companies plan to conduct an outcome trial to support full approval of mipomersen for hoFH and to expand its indication to include other patients with high cholesterol who are at high risk for cardiovascular events. In response to the FDA's...

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