Hereditary Angioedema
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2021-03-04Clinical Trial Update: Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan [Phase 3]
This clinical trial update reports the completion of a Phase 3 study evaluating BCX7353, an oral therapy, for preventing hereditary angioede…
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CLINICAL_TRIALS trial_result · 2021-03-04Clinical Trial Update: Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema [Phase 2]
Phase 2 trial updating efficacy and safety of BCX7353 to prevent angioedema attacks in hereditary angioedema (HAE).
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CLINICAL_TRIALS trial_result · 2021-03-02Clinical Trial Update: Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE [Phase 3]
Phase 3 trial update for BCX7353 as an oral preventive treatment for hereditary angioedema (HAE) completed with posted results.
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CLINICAL_TRIALS trial_result · 2021-02-01Clinical Trial Update: A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route [Phase 1, Phase 2]
A clinical trial evaluating the pharmacology and safety of subcutaneously administered C1-esterase inhibitor in hereditary angioedema types …
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CLINICAL_TRIALS trial_result · 2021-01-29Clinical Trial Update: A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema [Phase 3]
Phase 3 trial evaluating subcutaneous C1-esterase inhibitor for prevention of hereditary angioedema completed.
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FDA approval · 2020-12-28FDA Approved: KALBITOR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for Kalbitor (ecallantide) submitted by Takeda Pharmaceuticals America, Inc.
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FDA approval · 2020-12-03FDA Approved: ORLADEYO — Original Application (BioCryst Pharmaceuticals, Inc.)
The FDA approved ORLADEYO (berotralstat hydrochloride) from BioCryst Pharmaceuticals via an original application for prophylaxis to prevent …
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FDA approval · 2020-09-25FDA Approved: ICATIBANT — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for icatibant from Teva Pharmaceuticals USA, Inc. The action updates or adds to the existing labelin…
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FDA approval · 2020-09-25FDA Approved: ICATIBANT — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for ICATIBANT submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2020-07-13FDA Approved: SAJAZIR — Original Application (Cycle Pharmaceuticals Ltd-Uk)
FDA approved SAJAZIR (icatibant) under an original ANDA from Cycle Pharmaceuticals Ltd-Uk, establishing a generic icatibant option for treat…
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FDA approval · 2020-06-18FDA Approved: ICATIBANT — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's generic icatibant (ANDA 208317) for the treatment of acute attacks of hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2020-05-11Clinical Trial Update: Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE [Phase 3]
Phase 3 long-term safety and efficacy study of DX-2930 (SHP643) for preventing acute angioedema attacks in patients with Hereditary Angioede…
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FDA approval · 2020-04-16FDA Approved: FIRAZYR — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for FIRAZYR (icatibant acetate) submitted by Takeda Pharmaceuticals America, Inc. This action consti…
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FDA approval · 2020-03-09FDA Approved: ICATIBANT — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma's generic icatibant under ANDA211021 for the treatment of acute attacks of hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2019-08-08Clinical Trial Update: A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants [Phase 3]
Phase 3 trial of icatibant for acute attacks of hereditary angioedema in Japanese participants completed; results posted in 2019.
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FDA approval · 2019-07-15FDA Approved: ICATIBANT — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's original application for icatibant, a generic formulation for the treatment of acute attacks of hereditary angioedema.
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CLINICAL_TRIALS trial_result · 2019-03-25Clinical Trial Update: A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema [Phase 3]
Phase 3 pharmacokinetic, tolerability, and safety study of icatibant in children and adolescents with hereditary angioedema has completed wi…
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CLINICAL_TRIALS research · 2019-02-05Clinical Trial Update: Global Registry to Gather Data on Natural History of Patients With Hereditary Angioedema Type I and II
A clinical trial registry update about a global registry gathering natural history data for hereditary angioedema (types I and II).
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CLINICAL_TRIALS trial_result · 2018-12-31Clinical Trial Update: Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) [Phase 3]
Phase 3 trial of C1 inhibitor (human) for prevention and treatment of breakthrough attacks in Japanese subjects with hereditary angioedema h…
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CLINICAL_TRIALS trial_result · 2018-11-28Clinical Trial Update: Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema [Phase 3]
A Phase 3 study evaluated subcutaneously administered C1 esterase inhibitor for prevention of angioedema attacks in adolescents and adults w…
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CLINICAL_TRIALS trial_result · 2018-11-14Clinical Trial Update: A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema [Phase 3]
Phase 3 trial evaluating long-term safety and efficacy of subcutaneously administered C1-esterase inhibitor for prevention of hereditary ang…
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EMA approval · 2018-10-19New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin
EMA announces a new medicine for hereditary angioedema, a rare disorder characterized by swelling beneath the skin.
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CLINICAL_TRIALS trial_result · 2018-09-06Clinical Trial Update: Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects [Phase 1]
Phase 1 study evaluating safety, tolerability, and pharmacokinetics of recombinant human C1 esterase inhibitor in healthy adults completed; …
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CLINICAL_TRIALS trial_result · 2018-08-28Clinical Trial Update: Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema [Phase 3]
Phase 3 trial assessing safety and efficacy of CINRYZE for prevention of angioedema attacks in children 6-11 with hereditary angioedema; stu…
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FDA approval · 2018-08-23FDA Approved: TAKHZYRO — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approved TAKHZYRO (lanadelumab-flyo) from its original application for the prevention of attacks in patients with hereditary angioedema.