Familial Hypercholesterolemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-05-19FDA Approved: ATORVASTATIN CALCIUM — Original Application (Cipla USA Inc.,)
The FDA approved Cipla USA Inc.'s atorvastatin calcium tablet as an Original Application, enabling a generic atorvastatin calcium product to…
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FDA approval · 2016-05-05FDA Approved: SIMVASTATIN — Supplemental Application (Biocon Pharma Inc,)
FDA approved Biocon Pharma Inc.'s supplemental application for simvastatin (ANDA 078034). This confirms an approved modification to the gene…
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CLINICAL_TRIALS trial_result · 2016-03-08Clinical Trial Update: Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia [NA]
A clinical trial investigated how an LDL apheresis system influences gene expression related to lipoprotein metabolism and inflammation in h…
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FDA approval · 2016-02-24FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for atorvastatin calcium from Dr. Reddy's Laboratories Limited, authorizing the generic atorvastatin…
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CLINICAL_TRIALS trial_result · 2016-02-18Clinical Trial Update: Hyperapo B and Coronary Heart Disease
Clinical trial update on Hyperapo B evaluating its effect on coronary heart disease; the NHLBI-sponsored study has completed.
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FDA approval · 2016-01-27FDA Approved: FLUVASTATIN SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's generic fluvastatin sodium as an original ANDA, enabling its use to treat hyperlipidemia and reduce cardiovascular risk.
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CLINICAL_TRIALS trial_result · 2015-12-29Clinical Trial Update: Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia [Phase 1, Phase 2]
Phase 1/2 safety study of AEM-28 for refractory hypercholesterolemia completed; results were posted in 2015.
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CLINICAL_TRIALS trial_result · 2015-12-22Clinical Trial Update: Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2 [Phase 3]
Phase 3 trial update on reduction of LDL-C with PCSK9 inhibition in heterozygous familial hypercholesterolemia; results posted after complet…
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CLINICAL_TRIALS trial_result · 2015-12-21Clinical Trial Update: An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia [Phase 3]
An open-label extension of a Phase 3 trial assessing the long-term safety and efficacy of mipomersen in patients with familial hypercholeste…
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CLINICAL_TRIALS trial_result · 2015-11-06Clinical Trial Update: Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH) [Phase 3]
Phase 3 trial ODYSSEY HIGH FH evaluated alirocumab added to lipid-modifying therapy versus placebo in patients with heterozygous familial hy…
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FDA label_change · 2015-11-05FDA Approved: LESCOL XL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for LESCOL XL (fluvastatin sodium) submitted by Sandoz Inc, resulting in labeling changes.
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FDA approval · 2015-10-06FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries Inc.)
The FDA approved a supplemental application for atorvastatin calcium from Sun Pharmaceutical Industries Inc., granting regulatory approval f…
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CLINICAL_TRIALS trial_result · 2015-09-29Clinical Trial Update: Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study [Phase 2]
Phase 2 trial update on PCSK9 inhibition showing reduction of LDL cholesterol in individuals with heterozygous familial hypercholesterolemia…
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CLINICAL_TRIALS trial_result · 2015-09-22Clinical Trial Update: Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia [Phase 2]
Phase 2 study evaluating the safety and efficacy of evolocumab (REGN727/SAR236553) in heterozygous familial hypercholesterolemia; the trial …
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CLINICAL_TRIALS trial_result · 2015-09-04Clinical Trial Update: Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter
Clinical trial update reporting safety and efficacy results for the DALI LDL-adsorber and MONET Lipoprotein Filter in patients with familial…
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CLINICAL_TRIALS research · 2015-08-07Clinical Trial Update: MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR)
Clinical trial update investigating myocardial silent infarctions and fibrosis in patients with familial hypercholesterolemia (heterozygous)…
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CLINICAL_TRIALS research · 2015-07-02Clinical Trial Update: Atherosclerosis in Familial Hypercholesterolemia
A clinical trial update from University College London examines atherosclerosis in individuals with familial hypercholesterolemia; the curre…
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FDA approval · 2015-06-26FDA Approved: EZETIMIBE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved the original application for ezetimibe (generic) by Glenmark Pharmaceuticals Inc., USA.
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CLINICAL_TRIALS trial_result · 2015-06-24Clinical Trial Update: Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration [Phase 2]
Phase 2 clinical trial update evaluating mipomersen (ISIS 301012) and its effect on liver fat content in lipid metabolism disorders and hype…
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CLINICAL_TRIALS trial_result · 2015-06-02Clinical Trial Update: Atorvastatin Three Year Pediatric Study [Phase 3]
Phase 3 pediatric study of atorvastatin for familial hypercholesterolemia has completed with results posted in 2015.
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FDA approval · 2015-06-01FDA Approved: CRESTOR — Supplemental Application (AstraZeneca Pharmaceuticals LP)
FDA approved a supplemental application for CRESTOR (rosuvastatin) submitted by AstraZeneca Pharmaceuticals LP.
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FDA approval · 2015-04-28FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Quallent)
FDA approved a supplemental application for atorvastatin calcium (Quallent).
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CLINICAL_TRIALS trial_result · 2015-04-22Clinical Trial Update: Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone. [Phase 3]
Phase 3 study comparing the anti-atherosclerotic effect of torcetrapib added to atorvastatin versus atorvastatin alone has completed.
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FDA approval · 2015-04-15FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Pravastatin Sodium submitted by Aurobindo Pharma Limited, approving this generic statin product.
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CLINICAL_TRIALS trial_result · 2015-02-02Clinical Trial Update: An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia [Phase 3]
Phase 3 trial evaluating rosuvastatin in children and adolescents with familial hypercholesterolemia has completed and posted results.