Hereditary Angioedema
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CLINICAL_TRIALS trial_result · 2024-05-16Clinical Trial Update: Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
This clinical trial update notes the completion of a study evaluating social evaluative cold pressor testing in patients with hereditary ang…
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CLINICAL_TRIALS research · 2024-05-16Clinical Trial Update: A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema [Phase 1, Phase 2]
BioMarin's BMN 331 gene therapy trial for hereditary angioedema is described. The study is in Phase 1/2 and currently active but not recruit…
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: Autonomic Nervous System Profile in Hereditary Angioedema
This entry reports the completion of a clinical trial evaluating autonomic nervous system profile in patients with hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2024-03-29Clinical Trial Update: Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients [Phase 2]
Phase 2 trial update on safety of Ruconest in children aged 2-13 with hereditary angioedema has been completed with results posted.
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FDA approval · 2024-01-19FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FIRAZYR (icatibant acetate) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2023-11-21FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)
The FDA approved a supplemental application for ORLADEYO (berotralstat hydrochloride) from BioCryst Pharmaceuticals.
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FDA approval · 2023-08-14FDA Approved: ICATIBANT — Original Application (Eugia US LLC)
FDA approves the original ANDA for icatibant (generic) by Eugia US LLC for the treatment of acute hereditary angioedema attacks.
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FDA approval · 2023-07-24FDA Approved: SAJAZIR — Supplemental Application (Cycle Pharmaceuticals Ltd-Uk)
SAJAZIR (icatibant) received FDA approval of a supplemental application filed by Cycle Pharmaceuticals Ltd-Uk.
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CLINICAL_TRIALS trial_result · 2023-06-29Clinical Trial Update: CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks [Phase 3]
Phase 3 trial update for garadacimab (CSL312) in preventing hereditary angioedema attacks has completed with results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-06-26Clinical Trial Update: Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema [Phase 3]
Expanded access program update for lanadelumab in Japanese patients with hereditary angioedema; Phase 3 study completed and results posted.
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CLINICAL_TRIALS trial_result · 2023-06-18Clinical Trial Update: A Long Term Safety Study of BCX7353 in Hereditary Angioedema [Phase 2, Phase 3]
Long-term safety study of BCX7353 in hereditary angioedema has completed phases 2 and 3 with results posted.
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CLINICAL_TRIALS trial_result · 2023-02-08Clinical Trial Update: A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II [Phase 2]
A Phase II cross-over study evaluating the efficacy and safety of KVD900 (Sebetralstat) for on-demand treatment of hereditary angioedema att…
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FDA approval · 2023-02-03FDA Approved: TAKHZYRO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for TAKHZYRO (lanadelumab-flyo) from Takeda Pharmaceuticals America, Inc., to update and expand …
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CLINICAL_TRIALS trial_result · 2022-11-08Clinical Trial Update: A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) [Phase 2]
Phase 2 trial of CSL312 in hereditary angioedema completed; results posted in 2022.
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CLINICAL_TRIALS trial_result · 2022-09-28Clinical Trial Update: A Study to Assess the Clinical Efficacy of Donidalorsen (Also Known as IONIS-PKK-LRx and ISIS 721744) in Participants With Hereditary Angioedema [Phase 2]
Phase 2 clinical trial evaluating the efficacy of donidalorsen (IONIS-PKK-LRx/ISIS 721744) in hereditary angioedema has completed with poste…
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CLINICAL_TRIALS trial_result · 2022-09-19Clinical Trial Update: Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE) [Phase 3]
Phase 3 study evaluating efficacy and safety of lanadelumab (SHP643) in Japanese participants with hereditary angioedema has completed with …
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CLINICAL_TRIALS trial_result · 2022-05-26Clinical Trial Update: A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children [Phase 3]
Phase 3 clinical trial evaluating lanadelumab for preventing hereditary angioedema attacks in children has completed with results posted.
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FDA approval · 2022-04-28FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for FirazyR (icatibant acetate) submitted by Takeda Pharmaceuticals America, Inc. The approval u…
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CLINICAL_TRIALS trial_result · 2022-03-29Clinical Trial Update: A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema [Phase 3]
Phase 3 trial of icatibant (TAK-667) in Japanese children and adolescents with acute attacks of hereditary angioedema has completed with res…
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FDA approval · 2022-02-08FDA Approved: TAKHZYRO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved TAKHZYRO (lanadelumab-flyo) via a supplemental application from Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS withdrawal · 2022-02-04Clinical Trial Update: Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema [Phase 2, Phase 3]
The clinical trial comparing GNR-038 to Berinert for hereditary angioedema has been withdrawn.
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FDA approval · 2021-06-03FDA Approved: SAJAZIR — Supplemental Application (Cycle Pharmaceuticals Ltd-Uk)
FDA approved a supplemental application for SAJAZIR (icatibant) from Cycle Pharmaceuticals Ltd-Uk. This approval supports a generic icatiban…
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CLINICAL_TRIALS withdrawal · 2021-05-18Clinical Trial Update: Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema [Phase 2, Phase 3]
Clinical trial evaluating ecallantide in pediatric hereditary angioedema has been withdrawn (Phase 2/Phase 3).
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CLINICAL_TRIALS trial_result · 2021-05-18Clinical Trial Update: EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema [Phase 2]
Phase 2 clinical trial assessing DX-88 (conestat alfa) for reducing angioedema episodes in hereditary angioedema; study completed.
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CLINICAL_TRIALS trial_result · 2021-04-01Clinical Trial Update: Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema [Phase 2]
Phase 2 trial update for BCX7353 in hereditary angioedema completed with results posted in 2021.