Homozygous Familial Hypercholesterolemia
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FDA approval · 2014-08-08FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
The FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) from Amryt Pharmaceuticals DAC.
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FDA approval · 2014-04-23FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) filed by Amryt Pharmaceuticals DAC.
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FDA label_change · 2014-02-18FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
The FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC, resulting in a labeli…
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FDA approval · 2013-12-17FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
The FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.
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FDA approval · 2013-08-13FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
FDA approves a supplemental application for Juxtapid (lomitapide mesylate) by Amryt Pharmaceuticals DAC, resulting in updated labeling.
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FDA approval · 2013-04-10FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
FDA approves a supplemental application for JUXTAPID (lomitapide) submitted by Amryt Pharmaceuticals DAC. The action represents an additiona…
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CLINICAL_TRIALS trial_result · 2013-03-21Clinical Trial Update: Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 study evaluating mipomersen (ISIS 301012) for homozygous familial hypercholesterolemia has completed with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-02-22Clinical Trial Update: Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor [Phase 2]
Phase 2 results update on lomitapide, a microsomal triglyceride transfer protein inhibitor, evaluating safety, tolerability and efficacy in …
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CLINICAL_TRIALS trial_result · 2013-02-22Clinical Trial Update: A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH) [Phase 3]
Phase 3 safety and efficacy results for AEGR-733 in Homozygous Familial Hypercholesterolemia have been posted.
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FDA approval · 2012-12-21FDA Approved: JUXTAPID — Original Application (Amryt Pharmaceuticals DAC)
FDA approved Juxtapid (lomitapide) via an original application for homozygous familial hypercholesterolemia to reduce LDL cholesterol in aff…
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CLINICAL_TRIALS trial_result · 2012-05-24Clinical Trial Update: Efficacy of Lapaquistat Acetate Co-Administered With Current Lipid-Lowering Treatment on Blood Cholesterol Levels in Subjects With Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 trial evaluated adding Lapaquistat Acetate to standard lipid-lowering therapy for lowering cholesterol in Homozygous familial hyperc…
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FDA approval · 2011-12-01FDA Approved: VYTORIN — Supplemental Application (Organon LLC)
FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) by Organon LLC, updating its labeling and indications.
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CLINICAL_TRIALS trial_result · 2011-05-10Clinical Trial Update: Vytorin Reexamination Study (0653A-174)
Clinical trial update for the Vytorin reexamination study (0653A-174) completed with results posted in 2011.
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CLINICAL_TRIALS trial_result · 2009-07-14Clinical Trial Update: Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)
Clinical trial evaluating safety, tolerability, and efficacy of ezetimibe in a specific Filipino population with hypercholesterolemia has co…
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CLINICAL_TRIALS trial_result · 2008-08-29Clinical Trial Update: Bone Marrow Stem Cells as a Source of Allogenic Hepatocyte Transplantation in Homozygous Familial Hypercholesterolemia [Phase 1]
Phase 1 clinical trial evaluating allogenic hepatocyte transplantation from bone marrow-derived stem cells for homozygous familial hyperchol…
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FDA approval · 2008-06-05FDA Approved: ZETIA — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Zetia (ezetimibe) submitted by Organon LLC to update/expand aspects of its labeling.