CardioExchange Archive

March 22nd, 2013

Europe and U.S. Diverge on Two New Drugs

Larry Husten, PHD

The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the […]

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January 29th, 2013

FDA Approves Mipomersen for Homozygous Familial Hypercholesterolemia

Larry Husten, PHD

The FDA said today that it had granted approval to the novel cholesterol-lowering drug mipomersen sodium for use as an adjunct to diet and drug therapy in patients with homozygous hypercholesterolemia. The drug, which was developed by Isis Pharmaceuticals, will be marketed under the brand name of Kynamro by Genzyme. Kynamro was approved as an orphan drug, which the […]

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December 14th, 2012

CHMP Recommends Against Approval for Mipomersen in Europe

Larry Husten, PHD

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro; Isis and Genzyme) not be approved for use in Europe. The novel antisense oligonucleotide works by inhibiting the synthesis of apolipoprotein-B and is under development in the United States and Europe for the treatment of familial hypercholesterolemia. CHMP […]

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October 18th, 2012

FDA Panel Recommends Approval of Mipomersen for Homozygous Familial Hypercholesterolemia

Larry Husten, PHD

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave a weak endorsement to mipomersen, an antisense oligonucleotide inhibitor manufactured by Genzyme, for use in homozygous familial hypercholesterolemia (FH). With its relatively close 9-6 vote, and with its comments, the committee expressed concerns about both the efficacy and safety of the drug, but ultimately the severity of […]

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October 16th, 2012

FDA Review Raises Safety Concerns About Mipomersen

Larry Husten, PHD

An FDA review raises a number of potentially significant safety concerns about the cholesterol-lowering drug mipomersen. The review appears ahead of a Thursday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to evaluate Genzyme’s new drug application (NDA) for use of the drug as an adjunct to maximally tolerated lipid-lowering medications and diet to reduce […]

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