Familial Hypercholesterolemia News and Research

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Regeneron, Sanofi initiate enrollment in SAR236553/REGN727 Phase 3 program

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that several trials within ODYSSEY, the Phase 3 clinical program of SAR236553/REGN727, have initiated patient enrollment.

21 Jul 2012

FDA accepts NDA filing for KYNAMRO to treat HoFH

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., announced today that the U.S. Food and Drug Administration has accepted for filing the New Drug Application for KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).

29 May 2012

Positive results from Sanofi and Regeneron’s SAR236553/REGN727 Phase 2 trial on heFH

Sanofi and Regeneron Pharmaceuticals, Inc. today announced additional positive results from a Phase 2 trial of SAR236553/REGN727 in patients with heterozygous familial hypercholesterolemia (heFH).

28 May 2012

Experimental drugs from Sanofi and Regenron cut cholesterol in a new way

An experimental drug that acts in a novel way to lower cholesterol proved even more effective than statins and had few undesirable side effects, newly released data shows. The drug acts by modifying the way cholesterol levels are naturally controlled. A protein produced in the liver helps limit the amount of LDL, or “bad” cholesterol, that liver cells can remove from the bloodstream. The new drug, called REGN727, is a monoclonal antibody, made in a laboratory, that blocks the action of that protein.

27 Mar 2012

New cholesterol lowering drugs on the horizon

The new drugs in development by pharmaceutical makers are injectable medications that block a protein called PCSK9. These drugs have shown promise in early clinical trials for slashing bad LDL cholesterol further than widely used statins can alone. Their biggest advocates say PCSK9 blockers have the potential to be the next multibillion-dollar class of heart drugs.

25 Mar 2012

Regeneron reports total revenues of $123.0M for fourth quarter 2011

Regeneron Pharmaceuticals, Inc. announced financial and operating results for the fourth quarter and full year 2011 and provided an update on development programs.

13 Feb 2012

Karo Bio initiates patient recruitment in eprotirome phase III trial for HeFH

The first patient has now been included in Karo Bio's phase III trial with eprotirome. A total of 630 patients with the hereditary condition HeFH will be studied for safety, and to confirm the beneficial effects on LDL-cholesterol that has been shown previously.

4 Oct 2011

Karo Bio receives approval to initiate eprotirome phase III study in HeFH

Karo Bio AB has received approval from national regulatory authorities to start its phase III patient study with eprotirome, enabling the study to start as planned with an Investigators meeting in September.

19 Sep 2011

Isis, Genzyme submit European MAA for mipomersen to treat familial hypercholesterolemia

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc. today announced that Genzyme has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe heterozygous familial hypercholesterolemia.

28 Jul 2011

Alkem, Karo Bio partner to license eprotirome

Karo Bio has entered into a collaboration and license agreement with the Indian pharmaceutical company Alkem Laboratories Ltd.

26 Apr 2011

Genzyme, Isis present mipomersen phase 3 study data in severe heFH at ACC meeting

Genzyme Corp., a subsidiary of sanofi-aventis Group, and Isis Pharmaceuticals Inc. announced today that data from two phase 3 studies of mipomersen in patients who had high cholesterol levels while on lipid-lowering therapy were presented at the American College of Cardiology's 60th Annual Scientific Session.

6 Apr 2011

Study sheds light on novel functions of certain PCSK enzymes

Recent studies conducted at the Institut de recherches cliniques de Montr-al on a group of PCSK enzymes could have a positive impact on health, from cholesterol to osteoporosis.

17 Feb 2011

Aegerion third quarter net loss increases to $6.2 million

Aegerion Pharmaceuticals, Inc., an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat severe lipid disorders, announced its financial results and business highlights for the third quarter ended September 30, 2010.

30 Nov 2010

Impax initiates challenge of patents relating to WELCHOL

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.

22 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Alnylam to present data on RNAi therapeutics for fibrotic diseases at The Liver Meeting

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it will present several poster presentations at the 61st Annual Meeting of the American Association for the Study of Liver Diseases being held in Boston, Mass from October 29 - November 2, 2010.

30 Oct 2010

Genzyme third quarter revenue increases to $1.0 billion

Genzyme Corp. today reported third-quarter earnings growth driven by increased shipments of Cerezyme® (imiglucerase for injection). Patients in the United States began returning to normal dosing levels last month, and patients globally are expected to be able to do so this quarter. Earnings growth in the third quarter was also driven by strong revenue from Lumizyme™ (alglucosidase alfa) and cost reduction measures.

21 Oct 2010

Aegerion Pharmaceuticals’ MTP-I Phase III trial published in Atherosclerosis online supplement

ACR Image Metrix, a global imaging contract research organization (CRO) with expertise in imaging trial design, techniques and data extraction, is pleased to announce a Phase III trial, conducted for Aegerion Pharmaceuticals, Inc., was published as an abstract in the online supplement of Atherosclerosis and presented at the 78th European Atherosclerosis Society Congress, which took place June 20-23, 2010, in Hamburg, Germany.

6 Oct 2010

USFDA grants Sun Pharma subsidiary tentative approval for generic Crestor ANDA

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of IPR Pharmaceutical's Crestor ® tablets 5 mg, 10 mg, 20 mg, 40 mg.

30 Sep 2010

Mipomersen Phase 3 trial in heFH meets primary, secondary and tertiary endpoints

Genzyme Corp. and Isis Pharmaceuticals Inc. announced that data from the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) were presented today at the European Society of Cardiology's Congress 2010 in Stockholm, Sweden. The study met its primary endpoint with a 28 percent reduction in LDL-cholesterol, compared with an increase of 5 percent for placebo (p<0.001). The trial also met all of its secondary and tertiary endpoints.

2 Sep 2010