–For younger adults, study finds low yield of 10-year risk-based screening A new study provides ammunition to supporters of a conservative approach to initiating cholesterol tests in younger adults. But proponents of a more aggressive approach argue that the interpretation does not take into account the enormous burden of cardiovascular disease as people grow older….
Universal Child FH Screening Proposed
October 26, 2016 by 1 Comment
–Novel strategy would identify both children and adults at high risk for CV events. Doctors in the U.K. are proposing a novel strategy to identify very young children with familial hypercholesterolemia (FH). The strategy would also identify and help prevent events in the parents who also have FH. The new approach begins with a heel-stick…
Not So Rare, FH Is Truly Risky Lipid Disorder
April 3, 2016 by Leave a Comment
–Not all elevated is LDL is equally dangerous CHICAGO — Familial hypercholesterolemia (FH), a condition that has long been overshadowed by more common cardiovascular diagnoses, has now found the spotlight in the big tent as a hot and even controversial topic. The new interest is driven by important advances in understanding the genetics of the…
New Definition Of Familial Hypercholesterolemia Could Expand Patient Population For Expensive Cholesterol Drugs
November 5, 2015 by 4 Comments
More people may be diagnosed with familial hypercholesterolemia (FH) using criteria contained in a new scientific statement published by the American Heart Association. The expanded definition could also mean more patients will be eligible to receive expensive cholesterol-lowering drugs, including the new PCSK9 inhibitor drugs, (Repatha from Amgen and Praluent from Sanofi/Regeneron). But the biggest impact might be to increase the…
Desperately Seeking Patients: New Cholesterol Drug Makers Fuel Research To Find Customers
October 15, 2015 by 3 Comments
Everyone expects that the makers of the new PCSK9 inhibitor cholesterol lowering drugs are going to make billions and billions of dollars from these innovative new drugs. But before that can happen the companies that make the drugs will need to find the patients who will take the drug. To help find these patients a central strategy…
FDA Panel Recommends Approval Of Mipomersen For Familial Hypercholesterolemia
October 18, 2012 by 1 Comment
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…
FDA Reviewers Recommend Approval For Lomitapide For Homozygous Familial Hypercholesterolemia
October 17, 2012 by 2 Comments
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern that the drug might be used in lower…
FDA Review Raises Safety Concerns About Mipomersen
October 16, 2012 by 1 Comment
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…
FDA Reviewers Raise No New Red Flags Over Lomitapide
October 15, 2012 by 1 Comment
FDA reviewers have raised no new concerns about lomitapide ahead of a Wednesday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The FDA today released briefing documents that evaluate the new drug application (NDA) for lomitapide capsules, the microsomal triglyceride transfer protein (MTP) inhibitor from Aegerion Pharmaceuticals for use as an adjunct to a low-fat diet and…
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