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January 29, 2013
18:11 EDTSNYFDA approves new orphan drug Kynamro to treat inherited cholesterol disorder
The U.S. Food and Drug Administration today approved Kynamro injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia. The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol, apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol. The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH. On average, levels of LDL-C fell by about 25% during the first 26 weeks in those receiving the drug. The FDA approved Kynamro with a risk evaluation and mitigation strategy with elements to assure safe use, including prescriber and pharmacy certification, and documentation of safe-use conditions, which requires a prescription authorization form for each new prescription. Kynamro is manufactured by Cambridge, Mass.-based Genzyme Corp, which is owned by Sanofi (SNY). Reference Link
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December 9, 2014
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
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