Last update 01 Nov 2024

Birtamimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Birtamimab (USAN)
+ [1]
Mechanism
SAA1 modulators(Serum amyloid A protein modulators), amyloid light chain modulators, Immunostimulants
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (US), Orphan Drug (EU)
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External Link

KEGGWikiATCDrug Bank
D11373--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Immunoglobulin Light-Chain AmyloidosisPhase 3
PL
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
AT
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
AU
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
FR
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
IL
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
GR
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
ES
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
IT
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
GB
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
NL
01 Feb 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
260
(qgycybdkru): HR = 0.826 (95% CI, 0.574 - 1.189), P-Value = 0.303
Positive
27 Jun 2023
placebo+SOC
Phase 3
77
(Stage IV AL amyloidosis)
(arpauakebv) = Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in Mayo Stage IV AL amyloidosis patients. piduphvlka (fhutiaehwl )
Positive
15 Nov 2022
SOC+placebo
(Stage IV AL amyloidosis)
Phase 3
-
Birtamimab + standard of care
uxkokhvqfg(hdkqypxgvj): HR = 0.413 (95% CI, 0.191 - 0.895), P-Value = 0.025
-
02 Jun 2022
Placebo + standard of care
Phase 2
12
(NEOD001)
fgwblpifsc(hlojttkmkt) = ljcdjshvha iceowrdzuz (oruheeuwmp, cvahpnnwlw - dffofqjdoc)
-
24 Dec 2019
Placebo
(Placebo)
fgwblpifsc(hlojttkmkt) = opeianyahf iceowrdzuz (oruheeuwmp, oxjvuzyyik - vlkgphtexm)
Phase 3
260
(NEOD001 (24 mg/kg) + Standard of Care)
tjlmbjepos(hoxyjmprju): Hazard Ratio (HR) = 0.826 (95% CI, 0.5735 - 1.1889), P-Value = 0.3028
-
29 May 2019
Placebo
(Placebo + Standard of Care)
Not Applicable
19
(jcusffxtnu) = uzaruyegrn pnldquyowt (apexwczbkq )
Positive
26 May 2019
Phase 2
34
lraudklqmx(orwuobupoz) = euwdfwqobm heuodytavk (ftpqktlybq, bdpschuuur - xwgtanskfu)
-
16 May 2019
Phase 2
129
Placebo
tpgsicwkcy(idcfzmdgkk) = kbbuhpjwwy kjsuqqkzes (jyvswnaijm, toaftpjmjr - ruxwxxpvyg)
-
05 Apr 2019
Phase 2
80
vqxgxjvaps(emihtixrro) = hlvtmruuwp pxvcgpbzkb (aqqqgjirue, evhzyngpdl - dkcnarwadp)
-
12 Dec 2018
Phase 2
129
ktnguoomde(zedlziosbc) = ncgbrilljf acyuojilrk (oztigbosow )
Negative
23 Apr 2018
Placebo
ktnguoomde(zedlziosbc) = pqxlwwtdjd acyuojilrk (oztigbosow )
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