Phase III trials initiated 8/08; positive Phase III data reported 5/09; met primary endpoint in a late-stage trial, cutting levels of LDL by an average of 25% (up to 70-80% reduction) 11/09; expected NDA submission in mid-2011; as reported 2/10 when used in heterozygous familial hypercholesterolemia (heFH) mipomersen met its primary endpoint of reduction in LDL; however investors are concerned with recurring safety issues, particularly increased liver enzymes in some patients; data published in Lancet study, mipomersen met its primary endpoint, resulting in an average LDL-C reduction of greater than 100 mg/dL in homozygous familial hypercholesterolemia (hoFH) 3/10; positive phase III data 8/10, with expected NDA submission 1H2011
Brand N/A Generic mipomersen
Company name Genzyme, Isis Product type Non-speciality
Therapeutic category Cardiovascular agents Key uses Dyslipidemic
Other Uses N/A Drug Class antisense drug that reduces the production of apoB-100 protein
Dosage From SC Expected Approval 2012-Q1
FDA Filing N/A Last Update date August 09,2010
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Link to published data
Link to clinicaltrials.gov
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