Hereditary Angioedema
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-19EMA Authorised: Andembry (garadacimab) — CSL Behring GmbH
European Medicines Agency authorises Andembry (garadacimab) for hereditary angioedema.
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EMA approval · 2026-08-06EMA Authorised: Firazyr (icatibant) — Takeda Pharmaceuticals International AG
Authorised status for Firazyr (icatibant) by EMA for hereditary angioedema; MAH Takeda Pharmaceuticals International AG.
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EMA approval · 2026-08-03EMA Authorised: Takhzyro (lanadelumab) — Takeda Pharmaceuticals International AG Ireland Branch
EMA has authorised Takhzyro (lanadelumab) by Takeda for hereditary angioedema with accelerated assessment and orphan designation.
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EMA approval · 2026-07-21EMA Authorised: Takhzyro (lanadelumab) — Takeda Pharmaceuticals International AG Ireland Branch
EU authorization for Takhzyro (lanadelumab) by Takeda for hereditary angioedema, with orphan designation and accelerated assessment.
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EMA approval · 2026-07-14EMA Authorised: Ekterly (sebetralstat) — Kalvista Pharmaceuticals (Ireland) Limited
Ekterly (sebetralstat) has been authorised in the EU for hereditary angioedema, with Kalvista Pharmaceuticals (Ireland) Limited as the marke…
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EMA approval · 2026-04-16EMA Authorised: Icatibant Accord (icatibant acetate) — Accord Healthcare S.L.U.
The EMA authorised Icatibant Accord (icatibant acetate) for hereditary angioedema, with Accord Healthcare S.L.U. as the marketing authorizat…
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EMA approval · 2026-04-01EMA Authorised: Firazyr (icatibant) — Takeda Pharmaceuticals International AG
The European Medicines Agency authorised Firazyr (icatibant) by Takeda Pharmaceuticals International AG for hereditary angioedema.
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EMA approval · 2026-02-20EMA Authorised: Dawnzera (donidalorsen) — Otsuka Pharmaceutical Netherlands B.V.
EMA authorised Dawnzera (donidalorsen) for hereditary angioedema. The product is developed by Otsuka Pharmaceutical Netherlands B.V.
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EMA approval · 2026-02-18EMA Authorised: Orladeyo (berotralstat dihydrochloride) — BioCryst Ireland Limited
The EMA authorised Orladeyo (berotralstat dihydrochloride) for hereditary angioedema, with BioCryst Ireland Limited as the marketing authori…
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FDA approval · 2025-12-23FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)
FDA approval of a supplemental application for ORLADEYO (berotralstat hydrochloride) submitted by BioCryst Pharmaceuticals, Inc.
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EMA approval · 2025-12-19EMA Authorised: Ruconest (recombinant human C1-inhibitor) — Pharming Group N.V.
The EMA authorised Ruconest (recombinant human C1-inhibitor) for hereditary angioedema, with marketing authorization granted to Pharming Gro…
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FDA approval · 2025-12-11FDA Approved: ORLADEYO — Original Application (BioCryst Pharmaceuticals, Inc.)
FDA approves ORLADEYO (berotralstat hydrochloride) from BioCryst as an oral prophylaxis to prevent attacks of hereditary angioedema.
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EMA approval · 2025-10-08EMA Authorised: Ekterly (sebetralstat) — Kalvista Pharmaceuticals (Ireland) Limited
The EMA authorised Ekterly (sebetralstat) from Kalvista Pharmaceuticals for the treatment of hereditary angioedema, marking an approved ther…
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EMA approval · 2025-10-02EMA Authorised: Takhzyro (lanadelumab) — Takeda Pharmaceuticals International AG Ireland Branch
The EMA authorised lanadelumab (Takhzyro) for hereditary angioedema, with orphan medicine designation and accelerated assessment.
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FDA approval · 2025-08-21FDA Approved: DAWNZERA — Original Application (Ionis Pharmaceuticals Inc.)
The FDA approved Dawnzera (donidalorsen) from Ionis Pharmaceuticals as an original new drug for the prevention of hereditary angioedema atta…
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CLINICAL_TRIALS approval · 2025-08-06Clinical Trial Update: Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat
Regulatory approval for sebetralstat to treat angioedema attacks in adolescents and adults aged 12 years and older with hereditary angioedem…
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FDA approval · 2025-07-03FDA Approved: EKTERLY — Original Application (KalVista Pharmaceuticals Ltd)
FDA approved EKTERLY (SEBETRALSTAT) from KalVista Pharmaceuticals Ltd through an original NDA for the treatment of hereditary angioedema.
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EMA approval · 2025-06-18EMA Authorised: Cinryze (C1 inhibitor (human)) — Takeda Manufacturing Austria AG
The European Medicines Agency authorised Cinryze for hereditary angioedema, with Takeda Manufacturing Austria AG as the marketing authorizat…
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FDA approval · 2025-06-16FDA Approved: ANDEMBRY — Original Application (CSL)
The FDA approved ANDEMBRY (garadacimab) from CSL Behring under BLA761367, marking the first approval of this therapy. It is indicated for he…
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FDA approval · 2025-05-09FDA Approved: ICATIBANT — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for ICATIBANT submitted by Fresenius Kabi USA, LLC, finalizing changes to the product as described i…
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EMA approval · 2025-03-11EMA Authorised: Andembry (garadacimab) — CSL Behring GmbH
The EMA authorized Andembry (garadacimab) for hereditary angioedema. CSL Behring GmbH is the marketing authorization holder.
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FDA approval · 2025-01-03FDA Approved: ICATIBANT — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for icatibant (generic icatibant) under ANDA 211021.
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FDA approval · 2024-10-22FDA Approved: ICATIBANT — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for icatibant by Eugia US LLC under an Abbreviated New Drug Application (ANDA), marking regulato…
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FDA approval · 2024-10-21FDA Approved: ORLADEYO — Supplemental Application (BioCryst Pharmaceuticals, Inc.)
The FDA has approved a supplemental application for ORLADEYO (berotralstat hydrochloride) by BioCryst Pharmaceuticals, Inc. The approval add…
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FDA approval · 2024-09-03FDA Approved: ICATIBANT — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for icatibant from Teva Pharmaceuticals USA, Inc.