Sanofi/Genzyme And Isis Submit Kynamro For Lowering Cholesterol

It’s been a long haul, but Sanofi’s Genzyme business unit and Isis have submitted their NDA for a drug that helps lower cholesterol levels in high-risk patients with a rare genetic cardiovascular disease that doesn’t respond well to statins.

Long-term liver toxicities do not appear to be a significant problem for Kynamro, a second-generation anti-sense drug that manages severe high cholesterol in patients with a rare inherited genetic disease, the companies sponsoring the drug, Sanofi/Genzyme Corp. and partner Ionis Pharmaceuticals Inc. say.

Results of a two-year, ongoing, open extension study incorporating patients from a Phase III program for the drug found that...

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