Familial Hypercholesterolemia News and Research

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Study demonstrates rarity of familial hypercholesterolemia mutations in individuals with high cholesterol

Only a small fraction of people with very high cholesterol can attribute their condition to a genetic mutation related to familial hypercholesterolemia, but individuals with these mutations face a high risk of developing early-onset coronary artery disease, according to research presented at the American College of Cardiology's 65th Annual Scientific Session.

4 Apr 2016

PCSK9-inhibitor drugs: A game-changer for individuals with extremely high cholesterol levels

A 59-year-old heart patient with dangerously high levels of cholesterol that could not be adequately reduced by statin drugs now has near-normal cholesterol levels, thanks to a new class of drugs that grew out of work done by UT Southwestern Medical Center researchers.

27 Feb 2016

Amgen announces approval of cholesterol-lowering medication Repatha (evolocumab) Injection in Japan

Amgen today announced that the Japanese Ministry of Health, Labour and Welfare has approved the cholesterol-lowering medication Repatha (evolocumab) Injection, the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan.

22 Jan 2016

Urine-derived iPSCs model could help predict patient response to cholesterol-lowering drugs

We all know how important it is to keep our levels of blood cholesterol - especially the 'bad' variety - in check with a healthy diet and regular exercise. Although cholesterol is a key structural component of cell membranes and is vital for the biosynthesis of certain hormones and vitamins, high levels can lead to the formation of arterial plaques, which are a major risk factor for coronary heart disease.

20 Nov 2015

Repatha (evolocumab) injection gets FDA approval for high cholesterol

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

9 Oct 2015

Invitae announces dramatic expansion of genetic testing menu

Invitae Corporation (NYSE: NVTA), a genetic information company, has announced that it has more than doubled the size of its genetic testing platform to include more than 600 genes and will begin releasing the new content between now and the end of the year. Invitae is immediately expanding its menu with dozens of new test panels for hereditary cancer, cardiovascular, neuromuscular, pediatric and other rare disorders.

7 Oct 2015

Using deep learning to analyze genetic mutations: an interview with Brendan Frey

To understand deep learning in the context of genetic disease, you need to understand shallow learning first. Shallow learning relates mutations to diseases by looking for mutations that commonly occur in patients with a disease. It’s a commonly used method.

21 Sep 2015

New NIH grants support research that combines DNA sequence information and electronic medical records

A dozen awards from the National Institutes of Health will support research that incorporates DNA sequence information into electronic medical records. The goal of research conducted by the Electronic Medical Records and Genomics (eMERGE) network is to better understand the genomic basis of disease and to tailor medical care to individual patients based on their genomic differences.

2 Sep 2015

Familial hypercholesterolemia patients can benefit from alirocumab drug

Alirocumab lowers cholesterol in patients with heterozygous familial hypercholesterolemia to levels unreachable with statins alone, according to results from four ODYSSEY trials presented at ESC Congress today.

2 Sep 2015

Amgen to present data on Repatha (evolocumab) and observational studies at ESC Congress 2015

Amgen today announced that it will present six abstracts at the upcoming ESC Congress 2015, organized by the European Society of Cardiology, being held Aug. 29 – Sept. 2 in London.

26 Aug 2015

FDA approves Praluent (alirocumab) Injection for treatment of patients with high LDL cholesterol

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration approved Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors.

25 Jul 2015

EMA's CHMP recommends approval of Praluent (alirocumab) for use in patients with hypercholesterolemia

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia.

24 Jul 2015

Phase 3 ODYSSEY JAPAN trial of Praluent injection meets primary endpoint

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent® (alirocumab) Injection met its primary endpoint.

9 Jul 2015

Amgen to discuss data supporting Repatha BLA for high cholesterol treatment with FDA EMDAC

Amgen today announced that the Company will discuss the data supporting the Repatha (evolocumab) Biologics License Application (BLA) for the treatment of high cholesterol with the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).

10 Jun 2015

Amgen seeks marketing approval of Repatha (evolocumab) in Japan for treatment of high cholesterol

Amgen today announced that an application seeking marketing approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labour and Welfare in Japan.

21 Mar 2015

Type 2 diabetes less common in patients with familial hypercholesterolemia

The prevalence of type 2 diabetes among 25,000 patients with familial hypercholesterolemia (a genetic disorder characterized by high low-density lipoprotein [LDL] cholesterol levels) was significantly lower than among unaffected relatives, with the prevalence varying by the type of gene mutation, according to a study in the March 10 issue of JAMA.

11 Mar 2015

FDA accepts Amgen's evolocumab BLA for review

Amgen today announced that the U.S. Food and Drug Administration has accepted for review Amgen's Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol.

11 Nov 2014

Amgen seeks FDA approval for evolocumab to treat patients with high cholesterol

Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration for evolocumab seeking approval for the treatment of high cholesterol.

28 Aug 2014

Sanofi, Regeneron present alirocumab Phase 3 trial results at ESC Congress 2014

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that details from four pivotal trials in the alirocumab ODYSSEY clinical program will be presented on Sunday, August 31, during a Hot Line session at ESC Congress 2014 in Barcelona, Spain, the world's largest cardiology meeting.

25 Aug 2014

Cerenis’ SAMBA and MODE Phase II Studies Meet Primary Endpoints for Treatment of FPHA, HoFH

Cerenis Therapeutics, the biopharmaceutical company, today announced that two of its Phase II studies, SAMBA and MODE (Modifying Orphan Disease Evaluation), with CER-001, an engineered human apoA-I-containing pre-β HDL mimetic, met their primary clinical endpoints in patients with Familial Primary Hypoalphalipoproteinemia (FPHA) and Homozygous Familial Hypercholesterolemia (HoFH), respectively.

2 Jun 2014