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FDA Provides Clarity To Isis Regarding The Development Path For Mipomersen
Cholesterol Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) and Genzyme Corp. (Nasdaq: GENZ) 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).
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