Isis Updates KYNAMRO Submission Timeline

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Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that there will be a slight delay in the submission of the new drug application to the United States Food and Drug Administration for KYNAMRO.  This additional time will allow Genzyme to complete preparation of additional technical documentation. The submission of the U.S. NDA seeking approval of KYNAMRO for the treatment of homozygous familial hypercholesterolemia is now planned for the first quarter of 2012. In July of this year, Genzyme and Isis submitted a marketing authorization application to the European Medicines Agency seeking approval for KYNAMRO for the treatment of patients with homozygous and severe heterozygous FH.


 
 
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