Isis to Host Conference Call Today at 8 a.m. EDT
CARLSBAD, Calif. and CAMBRIDGE, Mass., April 25 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Genzyme Corp. (Nasdaq: GENZ) announced today 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 guidance, the companies are revising the development plan for mipomersen to accelerate plans for an outcome study. Isis and Genzyme plan to communicate further details of the revised development plan as they are finalized.
"Because our development plan, and our joint plan with Genzyme, has
always included outcome studies to maximize the profile and commercial
potential of mipomersen, this FDA guidance accelerates these planned
studies and simplifies the overall development path for mipomersen," said
Dr Stan Crooke, Chairman and Chie
|SOURCE Genzyme Corp. and Isis Pharmaceuticals, Inc.|
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