The FDA has approved CSL's garadacimab-gxii (Andembry) for prophylactic use to prevent attacks of hereditary angioedema ( hashtag#HAE ) in patients 12 years of age and older. #MedSky #Pedsky
Full details and trial data: hubs.li/Q03sqzvX0
Full details and trial data: hubs.li/Q03sqzvX0
FDA approves garadacimab-gxii to prevent HAE attacks in patients aged 12 years, older
Garadacimab-gxii is the only treatment to target factor Xlla for prophylactic use to prevent attacks of HAE in patients aged 12 years and older.
hubs.li
June 17, 2025 at 2:21 PM
The FDA has approved CSL's garadacimab-gxii (Andembry) for prophylactic use to prevent attacks of hereditary angioedema ( hashtag#HAE ) in patients 12 years of age and older. #MedSky #Pedsky
Full details and trial data: hubs.li/Q03sqzvX0
Full details and trial data: hubs.li/Q03sqzvX0
The peer-reviewed version of our garadacimab manuscript is now online @Structure_CP!
Link to the article: https://authors.elsevier.com/c/1jUWp3SNvcAbrV
#cryoEM #antibody #epitopemapping
Link to the article: https://authors.elsevier.com/c/1jUWp3SNvcAbrV
#cryoEM #antibody #epitopemapping
November 22, 2024 at 11:31 AM
The peer-reviewed version of our garadacimab manuscript is now online @Structure_CP!
Link to the article: https://authors.elsevier.com/c/1jUWp3SNvcAbrV
#cryoEM #antibody #epitopemapping
Link to the article: https://authors.elsevier.com/c/1jUWp3SNvcAbrV
#cryoEM #antibody #epitopemapping
#hereditaryangioedema #HAE #CSL #ANDEMBRY #garadacimab #factorXIIa #hereditaryangioedemaattacks #HAEattacks #factorXIIainhibitor #angioedema #HAEresearch #HAEtreatmentoptimisation #raredisease #geneticdisorder #HAEprevalence #VANGUARDclinicaltrial
pharmatimes.com/news/andembr...
pharmatimes.com/news/andembr...
Andembry treatment approved across Europe - PharmaTimes
Significant progress for hereditary angioedema condition
pharmatimes.com
February 18, 2025 at 10:47 AM
In summary, garadacimab Fab-βFXIIa structure provides crucial insights into its mechanism of action and delineates primary and auxiliary paratopes/epitopes.
This work reaffirms the benefits of #cryoEM as a primary tool to study antigen-antibody complexes in near-native state.
This work reaffirms the benefits of #cryoEM as a primary tool to study antigen-antibody complexes in near-native state.
November 22, 2024 at 12:31 PM
In summary, garadacimab Fab-βFXIIa structure provides crucial insights into its mechanism of action and delineates primary and auxiliary paratopes/epitopes.
This work reaffirms the benefits of #cryoEM as a primary tool to study antigen-antibody complexes in near-native state.
This work reaffirms the benefits of #cryoEM as a primary tool to study antigen-antibody complexes in near-native state.
'#CSL312 is also called #Garadacimab and is an antibody treatment that inhibits the plasma protein, FXIIa.
It is hoped the treatment will be useful in preventing the progression of coronavirus once patients experience respiratory distress..'
It is hoped the treatment will be useful in preventing the progression of coronavirus once patients experience respiratory distress..'
December 7, 2024 at 9:29 PM
'#CSL312 is also called #Garadacimab and is an antibody treatment that inhibits the plasma protein, FXIIa.
It is hoped the treatment will be useful in preventing the progression of coronavirus once patients experience respiratory distress..'
It is hoped the treatment will be useful in preventing the progression of coronavirus once patients experience respiratory distress..'
Garadacimab, a novel antibody, shows comparable pharmacokinetics and safety when administered via autoinjector/pre-filled pen versus pre-filled syringe, enabling at-home convenience for p...
🧵 Thread below
Full analysis: https://helixbrief.com/article/8f91c8e8-ecf9-4dbd-a9f8-0a00da127825
🧵 Thread below
Full analysis: https://helixbrief.com/article/8f91c8e8-ecf9-4dbd-a9f8-0a00da127825
November 1, 2025 at 11:12 AM
Garadacimab, a novel antibody, shows comparable pharmacokinetics and safety when administered via autoinjector/pre-filled pen versus pre-filled syringe, enabling at-home convenience for p...
🧵 Thread below
Full analysis: https://helixbrief.com/article/8f91c8e8-ecf9-4dbd-a9f8-0a00da127825
🧵 Thread below
Full analysis: https://helixbrief.com/article/8f91c8e8-ecf9-4dbd-a9f8-0a00da127825
Garadacimab, a novel, fully human recombinant monoclonal #antibody inhibitor of human-activated Factor XII (FXIIa), has recently completed its Phase 3 trial for the prophylactic treatment of Hereditary Angioedema (HAE) patients with C1-INH deficiency...
November 22, 2024 at 11:31 AM
Garadacimab, a novel, fully human recombinant monoclonal #antibody inhibitor of human-activated Factor XII (FXIIa), has recently completed its Phase 3 trial for the prophylactic treatment of Hereditary Angioedema (HAE) patients with C1-INH deficiency...
From needle-free epinephrine (Anaphylm) to FDA approval of garadacimab for HAE, here are 5 major allergy updates clinicians need to know. Check out our June allergy news recap here: www.hcplive.com/view...
#Allergy #FDA #Anaphylaxis #HAE #CRS #FoodAllergy
#Allergy #FDA #Anaphylaxis #HAE #CRS #FoodAllergy
Allergy Month in Review: June 2025
This month in review captures 5 allergy news in June, from FDA approvals to phase 3 data.
www.hcplive.com
July 2, 2025 at 1:00 AM
From needle-free epinephrine (Anaphylm) to FDA approval of garadacimab for HAE, here are 5 major allergy updates clinicians need to know. Check out our June allergy news recap here: www.hcplive.com/view...
#Allergy #FDA #Anaphylaxis #HAE #CRS #FoodAllergy
#Allergy #FDA #Anaphylaxis #HAE #CRS #FoodAllergy
#garadacimab beim hereditären #Angioödem: Anhaltspunkt für beträchtlichen Zusatznutzen
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile. Warum Hersteller ihre Wirkstoffe in dieser Indikation nach […]
[Original post on wisskomm.social]
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile. Warum Hersteller ihre Wirkstoffe in dieser Indikation nach […]
[Original post on wisskomm.social]
June 2, 2025 at 12:44 PM
#garadacimab beim hereditären #Angioödem: Anhaltspunkt für beträchtlichen Zusatznutzen
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile. Warum Hersteller ihre Wirkstoffe in dieser Indikation nach […]
[Original post on wisskomm.social]
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile. Warum Hersteller ihre Wirkstoffe in dieser Indikation nach […]
[Original post on wisskomm.social]
Garadacimab-gxii, anticuerpo monoclonal dirigido al factor XIIa SC una vez al mes, reduce los ataques de angioedema hereditario en pacientes de 12a o más firstwordpharma.com/story/5973298
FirstWord
firstwordpharma.com
June 21, 2025 at 7:16 AM
Garadacimab-gxii, anticuerpo monoclonal dirigido al factor XIIa SC una vez al mes, reduce los ataques de angioedema hereditario en pacientes de 12a o más firstwordpharma.com/story/5973298
In this study, led by the team at @CSL, we describe a 2.6 Å #cryoEM structure of βFXIIa complexed with the Fab fragment of garadacimab.
We observed three distinct garadacimab Fab-βFXIIa complexes and the C2-symmetric dimer chosen for epitope-paratope interface characterisation.
We observed three distinct garadacimab Fab-βFXIIa complexes and the C2-symmetric dimer chosen for epitope-paratope interface characterisation.
November 22, 2024 at 12:06 PM
In this study, led by the team at @CSL, we describe a 2.6 Å #cryoEM structure of βFXIIa complexed with the Fab fragment of garadacimab.
We observed three distinct garadacimab Fab-βFXIIa complexes and the C2-symmetric dimer chosen for epitope-paratope interface characterisation.
We observed three distinct garadacimab Fab-βFXIIa complexes and the C2-symmetric dimer chosen for epitope-paratope interface characterisation.
FDA clears Andembry (garadacimab-gxii) for hereditary angioedema ≥ 12 yrs. The VANGUARD trial showed over 99% median reduction in attacks; 62% went 6 months attack-free.
Read more: www.pharmacytimes.com/view/garadac...
Find the clinical evidence for Andembry at drugdocs.com/drug/Andembry
Read more: www.pharmacytimes.com/view/garadac...
Find the clinical evidence for Andembry at drugdocs.com/drug/Andembry
June 25, 2025 at 7:02 PM
FDA clears Andembry (garadacimab-gxii) for hereditary angioedema ≥ 12 yrs. The VANGUARD trial showed over 99% median reduction in attacks; 62% went 6 months attack-free.
Read more: www.pharmacytimes.com/view/garadac...
Find the clinical evidence for Andembry at drugdocs.com/drug/Andembry
Read more: www.pharmacytimes.com/view/garadac...
Find the clinical evidence for Andembry at drugdocs.com/drug/Andembry
These findings support the use of the more convenient AI/PFP for administering garadacimab, which could improve accessibility and adherence for patients with hereditary angioedema.
November 1, 2025 at 11:12 AM
These findings support the use of the more convenient AI/PFP for administering garadacimab, which could improve accessibility and adherence for patients with hereditary angioedema.
FDA approves first factor XIIa inhibitor, for hereditary angioedema nature.com/articles/d41...
CSL's first-in-class monoclonal antibody therapy garadacimab provides a once-monthly preventative option
CSL's first-in-class monoclonal antibody therapy garadacimab provides a once-monthly preventative option
July 14, 2025 at 2:51 PM
FDA approves first factor XIIa inhibitor, for hereditary angioedema nature.com/articles/d41...
CSL's first-in-class monoclonal antibody therapy garadacimab provides a once-monthly preventative option
CSL's first-in-class monoclonal antibody therapy garadacimab provides a once-monthly preventative option
Another nice example is this publication on garadacimab, where we showed what happened at different FOM concentrations (Fig. S3).
Image taken from the preprint: www.biorxiv.org/content/10.1...
Publication in Structure: www.cell.com/structure/ab...
Image taken from the preprint: www.biorxiv.org/content/10.1...
Publication in Structure: www.cell.com/structure/ab...
July 16, 2025 at 7:13 AM
Another nice example is this publication on garadacimab, where we showed what happened at different FOM concentrations (Fig. S3).
Image taken from the preprint: www.biorxiv.org/content/10.1...
Publication in Structure: www.cell.com/structure/ab...
Image taken from the preprint: www.biorxiv.org/content/10.1...
Publication in Structure: www.cell.com/structure/ab...
#Garadacimab beim hereditären #Angioödem: Anhaltspunkt für beträchtlichen Zusatznutzen
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile.
www.iqwig.de/presse/press...
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile.
www.iqwig.de/presse/press...
June 2, 2025 at 12:43 PM
#Garadacimab beim hereditären #Angioödem: Anhaltspunkt für beträchtlichen Zusatznutzen
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile.
www.iqwig.de/presse/press...
Ein indirekter Vergleich zeigt einen starken Rückgang der monatlichen Rate der Attacken und weitere Vorteile.
www.iqwig.de/presse/press...
This open-label, parallel-group, Phase 1 study in healthy adults compared the pharmacokinetics and safety of a single 200 mg subcutaneous injection of garadacimab administered via autoinjector/pre-filled pen (AI/PFP) versus pre-filled syringe (PFS).
November 1, 2025 at 11:12 AM
This open-label, parallel-group, Phase 1 study in healthy adults compared the pharmacokinetics and safety of a single 200 mg subcutaneous injection of garadacimab administered via autoinjector/pre-filled pen (AI/PFP) versus pre-filled syringe (PFS).
Garadacimab binds to βFXIIa through an unusually long CDR-H3 that inserts into the S1 pocket in a non-canonical way. This atypical structural mechanism is likely the primary contributor in the inhibition of activated FXII proteolytic activity in HAE.
November 22, 2024 at 12:14 PM
Garadacimab binds to βFXIIa through an unusually long CDR-H3 that inserts into the S1 pocket in a non-canonical way. This atypical structural mechanism is likely the primary contributor in the inhibition of activated FXII proteolytic activity in HAE.
Excited to share the results of a collaboration with @CSL:
Structural basis for inhibition of βFXIIa by garadacimab
https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
#garadacimab #antibody #cryoEM 🔬
A thread...🧵
Structural basis for inhibition of βFXIIa by garadacimab
https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
#garadacimab #antibody #cryoEM 🔬
A thread...🧵
November 22, 2024 at 11:22 AM
Excited to share the results of a collaboration with @CSL:
Structural basis for inhibition of βFXIIa by garadacimab
https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
#garadacimab #antibody #cryoEM 🔬
A thread...🧵
Structural basis for inhibition of βFXIIa by garadacimab
https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
#garadacimab #antibody #cryoEM 🔬
A thread...🧵
Structural basis for inhibition of βFXIIa by garadacimab https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
Structural basis for inhibition of βFXIIa by garadacimab https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
FXIIa is the principal initiator of the plasma contact system and can activate both procoagulant and
www.biorxiv.org
December 5, 2023 at 1:47 AM
Structural basis for inhibition of βFXIIa by garadacimab https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
Long-term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: Phase 3 open-label extension study scientiasalut.gencat.cat/handle/11351... #ScientiaVH
Long-term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: Phase 3 open-label extension study
scientiasalut.gencat.cat
March 10, 2025 at 8:29 AM
Long-term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: Phase 3 open-label extension study scientiasalut.gencat.cat/handle/11351... #ScientiaVH
Andembry (Garadacimab-gxii ) is a new drug in my very novel- Fast Pharmacology-Drug in 5 minutes season/series
Learn the basics about it in this episode
#pharmacology #doctor #medicalsciences #drradhikavijay #pharmacologypodcast #ispharmacologydifficult #audiopharmacology #podcast #newdrug
Learn the basics about it in this episode
#pharmacology #doctor #medicalsciences #drradhikavijay #pharmacologypodcast #ispharmacologydifficult #audiopharmacology #podcast #newdrug
September 12, 2025 at 1:40 PM
Andembry (Garadacimab-gxii ) is a new drug in my very novel- Fast Pharmacology-Drug in 5 minutes season/series
Learn the basics about it in this episode
#pharmacology #doctor #medicalsciences #drradhikavijay #pharmacologypodcast #ispharmacologydifficult #audiopharmacology #podcast #newdrug
Learn the basics about it in this episode
#pharmacology #doctor #medicalsciences #drradhikavijay #pharmacologypodcast #ispharmacologydifficult #audiopharmacology #podcast #newdrug
Structural basis for inhibition of βFXIIa by garadacimab https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
Structural basis for inhibition of βFXIIa by garadacimab https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
FXIIa is the principal initiator of the plasma contact system and can activate both procoagulant and
www.biorxiv.org
December 5, 2023 at 1:47 AM
Structural basis for inhibition of βFXIIa by garadacimab https://www.biorxiv.org/content/10.1101/2023.12.03.569829v1
#NICE #CSL #HAEtherapy #Andembry #garadacimab #PharmaNews #CSLBehring #hereditaryangioedema #HAE #NHS #NICEguidance #NICETAG #FactorXIIainhibitor #HAEpatients #raregeneticdisorder #MHRA #VANGUARDstudy #HAEattacks #HAEUK #AngelaMetcalfe #HAEprevention #EduardoCabas
pharmaphorum.com/news/nice-fi...
pharmaphorum.com/news/nice-fi...
NICE finalises support for CSL's HAE therapy Andembry
CSL Behring's Andembry can be used to prevent recurrent attacks of HAE by the NHS, following finalised guidance from reimbursement authority NICE
pharmaphorum.com
October 9, 2025 at 10:00 AM