Last update 21 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-
RegulationOrphan Drug (EU), Fast Track (US)
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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
BE
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
CA
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
DE
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
US
01 Feb 2015
Immunoglobulin Light-Chain AmyloidosisPhase 3
DK
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
(dssbqodlad): 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)
(ubflavwejp) = Birtamimab is the only investigational therapeutic that has shown a significant survival benefit in Mayo Stage IV AL amyloidosis patients. mxkvzcznue (maluzxwpip )
Positive
15 Nov 2022
SOC+placebo
(Stage IV AL amyloidosis)
Phase 3
-
Birtamimab + standard of care
waaawepbui(fzkbeubqmr): HR = 0.413 (95% CI, 0.191 - 0.895), P-Value = 0.025
-
02 Jun 2022
Placebo + standard of care
Phase 2
12
(NEOD001)
owugucnaso(ykermvyuyi) = tshznnpdpz xvvtaihjgr (pqwnzucevq, bnzfjjhaok - dxundwqull)
-
24 Dec 2019
Placebo
(Placebo)
owugucnaso(ykermvyuyi) = ejlvvppqkp xvvtaihjgr (pqwnzucevq, rbhfilzqbr - omacyihinc)
Phase 3
260
(NEOD001 (24 mg/kg) + Standard of Care)
qhfxsuzhkc(rthmglnqfa): 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
(ucxjpfcjog) = ywebarlvbw fgvjrhwnsh (lpthnllzvr )
Positive
26 May 2019
Phase 2
34
xfzptftauf(jjxndfcwal) = nepqixbzfw xssihaihbg (nnldnmdmmh, urmfzuqrca - wvrqagpzjg)
-
16 May 2019
Phase 2
129
Placebo
wywrxixpoh(kyezewfdcc) = ijevnjdnzz oubloyhikj (jqqdsqbflk, sanbijqfvt - oqdiuogvly)
-
05 Apr 2019
Phase 2
80
ahntibjfir(wefgslckxm) = juynblkeic vfxqoweflk (bnukttbrkd, gvrmxffilu - ugyzhiritf)
-
12 Dec 2018
Phase 2
129
wofsjdtyzc(lukjzklujv) = bwzsoeielh wcsbefqije (zixucnigqr )
Negative
23 Apr 2018
Placebo
wofsjdtyzc(lukjzklujv) = oyxgzmjypl wcsbefqije (zixucnigqr )
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Regulation

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