Homozygous Familial Hypercholesterolemia

• FDA approval · 2020-01-29
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Dr.Reddys Laboratories Inc)

  The FDA approved a supplemental application for the generic fixed-dose combination ezetimibe and simvastatin by Dr. Reddy's Laboratories. Th…

• FDA approval · 2019-12-20
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for JUXTAPID (lomitapide) from Amryt Pharmaceuticals DAC.

• CLINICAL_TRIALS trial_result · 2019-12-09
  Clinical Trial Update: Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH) [Phase 2]

  Phase 2 trial of REGN1500 in Homozygous Familial Hypercholesterolemia completed with results posted.

• FDA approval · 2018-10-26
  FDA Approved: EZETIMIBE — Original Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare Inc.'s original ANDA for a generic ezetimibe product, authorizing its marketing as a cholesterol-lowering tre…

• CLINICAL_TRIALS trial_result · 2018-05-11
  Clinical Trial Update: Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia [Phase 3]

  Phase 3 long-term follow-on study of lomitapide in patients with homozygous familial hypercholesterolemia. Results from the completed study …

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• CLINICAL_TRIALS trial_result · 2018-02-27
  Clinical Trial Update: A Study to Evaluate the Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia [Phase 3]

  A Phase 3 study evaluating the safety of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia. The trial i…

• CLINICAL_TRIALS withdrawal · 2018-02-22
  Clinical Trial Update: Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy [Phase 3]

  Phase 3 trial evaluating lomitapide in pediatric patients with homozygous familial hypercholesterolemia has been withdrawn.

• FDA approval · 2017-08-25
  FDA Approved: EZETIMIBE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for ezetimibe from Aurobindo Pharma Limited, enabling a generic version of the cholesterol-lowering dr…

• FDA approval · 2017-08-02
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.

• FDA approval · 2017-06-12
  FDA Approved: EZETIMIBE — Original Application (Sandoz Inc)

  FDA approved Sandoz Inc's original application for ezetimibe, a generic cholesterol-lowering medication. The approval confirms marketing aut…

• CLINICAL_TRIALS trial_result · 2017-02-20
  Clinical Trial Update: Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia

  A completed clinical trial from Central South University investigated gene analysis and treatment optimization for Homozygous Familial Hyper…

• FDA approval · 2017-01-19
  FDA Approved: VYTORIN — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for VYTORIN (ezetimibe and simvastatin) from Organon LLC.

• FDA approval · 2017-01-03
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) filed by Amryt Pharmaceuticals DAC.

• FDA label_change · 2016-07-11
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approves a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC, resulting in labeling cha…

• CLINICAL_TRIALS trial_result · 2016-07-04
  Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia [Phase 3]

  Phase 3 study evaluating rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia has completed, and results h…

• FDA approval · 2016-05-23
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for JUXTAPID (lomitapide) from Amryt Pharmaceuticals DAC.

• CLINICAL_TRIALS trial_result · 2016-03-09
  Clinical Trial Update: Study to Evaluate the Effects of MBX-8025 in Patients With HoFH [Phase 2]

  Phase 2 clinical trial update evaluating MBX-8025 in patients with Homozygous Familial Hypercholesterolemia; the study has completed.

• FDA approval · 2016-03-08
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  FDA approved Amryt Pharmaceuticals DAC's supplemental application for JUXTAPID (lomitapide mesylate).

• CLINICAL_TRIALS trial_result · 2016-03-08
  Clinical Trial Update: Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia

  This clinical trial update reports the completion of a study comparing two LDL apheresis systems in patients with homozygous familial hyperc…

• CLINICAL_TRIALS trial_result · 2015-10-02
  Clinical Trial Update: Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities [Phase 2, Phase 3]

  A Phase 2/3 trial evaluating a PCSK9 antibody in subjects with LDL receptor abnormalities (Homozygous Familial Hypercholesterolemia) has com…

• CLINICAL_TRIALS trial_result · 2015-08-18
  Clinical Trial Update: Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects [Phase 2]

  Phase 2 clinical trial update evaluating CER-001 for reducing plaque volume in adults with Homozygous familial hypercholesterolemia.

• CLINICAL_TRIALS trial_result · 2015-06-01
  Clinical Trial Update: Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042) [Phase 3]

  Phase 3 trial evaluating the efficacy and tolerability of adding anacetrapib to ongoing lipid-lowering therapy in adults with Homozygous Fam…

• FDA approval · 2015-04-24
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for Juxtapid (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.

• FDA approval · 2015-04-23
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC, granting changes to t…

• FDA approval · 2014-11-11
  FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)

  The FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.