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Isis, Sanofi Win FDA Panel Backing For Lipid Disorder Drug


Shares of Isis Pharmaceuticals Inc. (ISIS) were up more than 11% to $10.73 in after hours Thursday, after the company announced that its lipid disorder treatment Kynamro has won the backing of FDA panel.

Kynamro is a weekly injectable therapeutic that was licensed by Isis to Genzyme in 2008, which is now a unit of French pharmaceutical giant Sanofi (SNY).

Isis and Genzyme submitted a New Drug Application seeking approval of Kynamro for the treatment of homozygous familial hypercholesterolemia in March of this year. The FDA panel, which reviewed the NDA today, voted 9 to 6 recommending Kynamro for homozygous familial hypercholesterolemia, or HoFH.

Homozygous Familial Hypercholesterolemia is a rare genetic lipid disorder resulting in an accumulation of low-density lipoprotein, often referred to as bad cholesterol, in the blood.

The final decision of the FDA is scheduled for January 29, 2013. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

Isis shares have taken a beating in the last three days - cratering more than 27% to $9.62, after briefing documents released on Oct.16, ahead of the FDA panel meeting, raised concerns over abnormal growths, known as neoplasms, in 3.1% of the patients treated with the drug in clinical trials.

Commenting on the FDA panel decision, Lynne Parshall, COO and CFO of Isis said, "KYNAMRO could represent a significant advance for patients with HoFH, who are unable to adequately control their LDL-C and remain at significant risk of a cardiac event. We are pleased with the positive recommendation from the advisory committee and look forward to the FDA's decision early next year."

It was only a day earlier - Oct.17, that Aegerion Pharmaceuticals Inc.'s (AEGR) Lomitapide was voted 13 to 2 by the FDA panel recommending the drug for homozygous familial hypercholesterolemia. Lomitapide has a decision date set for December 29, 2012.

Aegerion shares touched a new high of $22.63 on Thursday before closing the day's trading at $20.94.

by RTTNews Staff Writer

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