Isis, Genzyme cholesterol drug to face one-year delay

The FDA has asked for more clinical trial data on cancer risk linked to mipomersen, a cholesterol treatment Isis Pharmaceuticals and Genzyme Corp. are working on, delaying regulatory approval for at least one year. The drugmakers said they will accelerate plans to conduct an outcomes study based on agency guidance in parallel with ongoing trials of the drug, which is intended to treat homozygous familial hypercholesterolemia.

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