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Disease Severity Underlies Advisory Committee Support For Kynamro

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Metabolic and Endocrinologic Advisory Committee votes 9 to 6 in favor of Genzyme’s mipomersen for homozygous familial hypercholesterolemia Oct. 18.

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Genzyme/Isis Build Simple, No Fuss Case For Weekly Cholesterol Injectable Kynamro

Genzyme and Isis are playing up mipomersen’s intrinsic qualities as they prepare to go head-to-head against Aegerion’s Juxtapid in the small homozygous familial hypercholesterolemia market. Kynamro also will carry a price tag that is $119,000 less than Juxtapid’s.

Genzyme/Isis Gear Up For Long-awaited Kynamro Launch

Genzyme said it is ready to deliver product, but complying with the REMS that helped pave the way for approval is a time-limiting factor for launching the familial hypercholesterolemia drug. Drug will be priced at $176,000 per year, significantly lower than Aegerion’s competing Juxtapid.

Aegerion Juxtapid Launch Targets Population Far Broader Than FDA Projection

Aegerion says feedback from key opinion leaders and market research indicate the market for its homozygous hypercholesterolemia drug may be as many as 3,000 patients; FDA estimates put the number at 315.

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