Heterozygous Familial Hypercholesterolemia

• CLINICAL_TRIALS trial_result · 2023-03-02
  Clinical Trial Update: A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 2]

  Phase 2 clinical trial of PCSK9 inhibitor AK102 in patients with heterozygous familial hypercholesterolemia has been completed.

• FDA approval · 2023-01-18
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved an original application for colesevelam hydrochloride by Amneal Pharmaceuticals of New York LLC, granting a generic version of …

• FDA approval · 2021-09-15
  FDA Approved: EZETIMIBE AND SIMVASTATIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for the ezetimibe and simvastatin combination product from Amneal Pharmaceuticals NY LLC.

• CLINICAL_TRIALS trial_result · 2021-08-25
  Clinical Trial Update: Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia [Phase 3]

  Phase 3 trial update evaluating PCSK9 inhibitors for efficacy and safety in patients with heterozygous familial hypercholesterolemia.

• CLINICAL_TRIALS trial_result · 2021-06-15
  Clinical Trial Update: Long Term Safety Study of PRALUENT [Phase 4]

  Phase 4 long-term safety study of PRALUENT has been terminated with results posted.

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• CLINICAL_TRIALS trial_result · 2020-10-28
  Clinical Trial Update: Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 3]

  Phase 3 trial evaluating Inclisiran's effect on LDL-C in patients with heterozygous familial hypercholesterolemia has completed with results…

• CLINICAL_TRIALS trial_result · 2020-08-05
  Clinical Trial Update: Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 2]

  Open-label extension study to assess long-term safety and efficacy of alirocumab in heterozygous familial hypercholesterolemia completed wit…

• FDA approval · 2020-07-29
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) from Cosette Pharmaceuticals, Inc., indicating an approv…

• CLINICAL_TRIALS trial_result · 2020-05-01
  Clinical Trial Update: Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy [Phase 3]

  Phase 3 trial studying alirocumab in patients with heterozygous familial hypercholesterolemia undergoing LDL apheresis has completed with re…

• FDA approval · 2020-04-07
  FDA Approved: ROSUVASTATIN CALCIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's supplemental application for ROSUVASTATIN CALCIUM, a generic rosuvastatin calcium product, under approved …

• FDA approval · 2020-02-26
  FDA Approved: NEXLIZET — Original Application (Esperion Therapeutics, Inc.)

  The FDA approved Nexlizet, a fixed-dose combination of bempedoic acid and ezetimibe, for adults with primary hyperlipidemia (including heter…

• FDA approval · 2020-02-21
  FDA Approved: NEXLETOL — Original Application (Esperion Therapeutics, Inc.)

  FDA approved Nexletol (bempedoic acid) as an original application for adults with heterozygous familial hypercholesterolemia or established …

• 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…

• CLINICAL_TRIALS trial_result · 2019-09-06
  Clinical Trial Update: An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia [Phase 2]

  Phase 2 dose-finding trial evaluating alirocumab in children and adolescents with heterozygous familial hypercholesterolemia has been comple…

• 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…

• FDA approval · 2018-05-18
  FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's colesevelam hydrochloride as an original application (ANDA) for lowering LDL cholesterol in adults with primary hype…

• CLINICAL_TRIALS trial_result · 2018-01-11
  Clinical Trial Update: A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384) [Phase 3]

  Phase 3 clinical trial evaluating long-term safety and tolerability of MK-0653C in Japanese participants with hypercholesterolemia; complete…

• 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 · 2017-05-19
  Clinical Trial Update: A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia [Phase 3]

  Phase 3, 52-week study of bococizumab in subjects with heterozygous familial hypercholesterolemia completed; results were posted in May 2017…

• FDA approval · 2016-11-23
  FDA Approved: ROSUVASTATIN CALCIUM — Original Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals' rosuvastatin calcium as an original generic product (ANDA 207453) for lowering cholesterol.

• CLINICAL_TRIALS trial_result · 2016-04-25
  Clinical Trial Update: A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050) [Phase 3]

  Phase 3 study evaluating safety and efficacy of adding Anacetrapib to ongoing statin therapy in Japanese participants with heterozygous fami…

• CLINICAL_TRIALS trial_result · 2015-11-04
  Clinical Trial Update: Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy [Phase 3]

  Phase 3 trial evaluating the efficacy and safety of Alirocumab added to lipid-modifying therapy in patients with heterozygous familial hyper…

• CLINICAL_TRIALS trial_result · 2015-10-28
  Clinical Trial Update: Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) [Phase 3]

  Phase 3 study evaluating Alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled on lipid-modifying…

• FDA approval · 2015-07-24
  FDA Approved: PRALUENT — Original Application (Regeneron Pharmaceuticals, Inc.)

  FDA approved the original application for PRALUENT (alirocumab) by Regeneron. It is indicated to lower LDL cholesterol in adults with hetero…

• FDA approval · 2014-05-20
  FDA Approved: WELCHOL — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Welchol (colesevelam hydrochloride) submitted by Cosette Pharmaceuticals, Inc. The action ap…