FDA clears Sanofi and Isis' Kynamro for inherited cholesterol disorder

The US Food and Drug Administration yesterday approved Sanofi (Euronext: SAN) subsidiary Genzyme’s orphan drug Kynamro (mipomersen sodium) injection as an addition to lipid-lowerers and diet to treat patients with a rare type of inherited high cholesterol called homozygous familial hypercholesterolemia (HoFH).

The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C). Kynamro is an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200,000 people. Last month, the FDA approved Aegerion’s Juxtapid (lomitapide) to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH (The Pharma Letter December 28, 2012).

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