Homozygous Familial Hypercholesterolemia
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FDA approval · 2024-07-10FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc., granting an update to the approved gene…
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CLINICAL_TRIALS trial_result · 2024-04-30Clinical Trial Update: Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia [Phase 3]
A Phase 3 trial evaluating long-term safety and efficacy of evinacumab in homozygous familial hypercholesterolemia has completed, with resul…
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FDA approval · 2024-03-29FDA Approved: EZETIMIBE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for ezetimibe filed by Quallent Pharmaceuticals Health LLC. This confirms approval of a new or m…
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FDA approval · 2024-02-21FDA Approved: ZETIA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Zetia (ezetimibe) from Organon LLC.
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FDA approval · 2024-02-02FDA Approved: EZETIMIBE — Supplemental Application (Marlex Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ezetimibe submitted by Marlex Pharmaceuticals, Inc. The action updates the approval status f…
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CLINICAL_TRIALS trial_result · 2023-08-09Clinical Trial Update: A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia [Phase 2, Phase 3]
A study evaluating safety and efficacy of IBI306, a PCSK9 monoclonal antibody, in Chinese subjects with homozygous familial hypercholesterol…
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CLINICAL_TRIALS trial_result · 2023-07-13Clinical Trial Update: A Gene Therapy Study for Homozygous Familial Hypercholesterolemia (HoFH) [Phase 1, Phase 2]
Phase 1/2 gene therapy trial for Homozygous Familial Hypercholesterolemia (HoFH) has been terminated; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-06-07Clinical Trial Update: Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 clinical trial results updating the efficacy and safety of evinacumab in pediatric patients with Homozygous Familial Hypercholestero…
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CLINICAL_TRIALS trial_result · 2023-03-29Clinical Trial Update: Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH [Phase 3]
Phase 3 trial evaluating LIB003 with evolocumab in Homozygous Familial Hypercholesterolemia has completed.
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FDA approval · 2023-03-21FDA Approved: EVKEEZA — Supplemental Application (Regeneron Pharmaceuticals, Inc.)
FDA approved a supplemental application for EVKEEZA (evinacumab) from Regeneron Pharmaceuticals, Inc. The approval updates the existing Biol…
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CLINICAL_TRIALS trial_result · 2023-03-02Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH [Phase 2]
Phase 2 trial evaluating safety and efficacy of AK102, a PCSK9 inhibitor, in patients with homozygous familial hypercholesterolemia complete…
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FDA approval · 2022-12-16FDA Approved: EZETIMIBE — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for EZETIMIBE from Amneal Pharmaceuticals NY LLC.
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CLINICAL_TRIALS trial_result · 2022-11-10Clinical Trial Update: A Study of Inclisiran in Participants With Homozygous Familial Hypercholesterolemia (HoFH) [Phase 3]
Phase 3 trial evaluating inclisiran for Homozygous Familial Hypercholesterolemia has completed with results posted.
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FDA approval · 2022-07-26FDA Approved: EZETIMIBE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original ANDA for ezetimibe tablets, a generic version of Zetia used to treat hyperlipidemia. The appro…
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FDA approval · 2022-06-16FDA 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 · 2022-02-01FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
FDA approves a supplemental application for JUXTAPID (lomitapide mesylate) submitted by Amryt Pharmaceuticals DAC.
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FDA approval · 2021-09-15FDA 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.
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CLINICAL_TRIALS trial_result · 2021-06-29Clinical Trial Update: Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH) [Phase 3]
A Phase 3 clinical trial in participants with homozygous familial hypercholesterolemia has completed and results were posted in 2021.
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FDA approval · 2021-05-27FDA Approved: JUXTAPID — Supplemental Application (Amryt Pharmaceuticals DAC)
FDA approved a supplemental application for JUXTAPID (lomitapide mesylate) from Amryt Pharmaceuticals DAC.
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CLINICAL_TRIALS trial_result · 2021-05-18Clinical Trial Update: Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 trial updates on the efficacy and safety of evinacumab in patients with Homozygous Familial Hypercholesterolemia.
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FDA approval · 2021-02-11FDA Approved: EVKEEZA — Original Application (Regeneron Pharmaceuticals, Inc.)
FDA approved the original Biologics License Application for EVKEEZA (evinacumab) from Regeneron Pharmaceuticals for the treatment of homozyg…
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CLINICAL_TRIALS trial_result · 2020-12-29Clinical Trial Update: An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 trial update evaluating alirocumab for efficacy and safety in children and adolescents with homozygous familial hypercholesterolemia…
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CLINICAL_TRIALS trial_result · 2020-11-03Clinical Trial Update: Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia [Phase 4]
Phase 4 trial update assessing safety and tolerability of Repatha (evolocumab) in Indian participants with Homozygous Familial Hypercholeste…
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CLINICAL_TRIALS trial_result · 2020-06-25Clinical Trial Update: Efficacy and Safety of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid-Lowering Therapy (COBALT-1) [Phase 2]
Phase 2 trial update on the efficacy and safety of gemcabene in patients with homozygous familial hypercholesterolemia on stable lipid-lower…
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CLINICAL_TRIALS trial_result · 2020-05-18Clinical Trial Update: A Study of ALN-PCSSC in Participants With Homozygous Familial Hypercholesterolemia (HoFH) [Phase 2]
Phase 2 trial update for ALN-PCSSC in participants with homozygous familial hypercholesterolemia has completed with results posted.