Last update 21 Nov 2024

Lanadelumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-plasma kallikrein mAb, Anti-plasma kallikrein monoclonal antibody, LANDELUMAB-FLYO
+ [14]
Mechanism
Kallikreins inhibitors
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (23 Aug 2018),
RegulationFast Track (US), Priority Review (AU), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hereditary Angioedema
US
23 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AngioedemaPhase 3
FR
04 May 2020
AngioedemaPhase 3
ES
04 May 2020
AngioedemaPhase 3
NL
04 May 2020
AngioedemaPhase 3
IT
04 May 2020
AngioedemaPhase 3
CA
04 May 2020
AngioedemaPhase 3
HU
04 May 2020
Hereditary AngioedemaPhase 2
PR
03 Mar 2016
Hereditary AngioedemaPreclinical
JO
03 Mar 2016
Hereditary AngioedemaPreclinical
PR
03 Mar 2016
Hereditary AngioedemaPreclinical
JO
03 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
ACAAI2024
ManualManual
Not Applicable
257
kqpiuwpggh(lvgetlwrba) = vgjahhzdth bqemnkdkcm (adzsunuplk )
Positive
24 Oct 2024
kqpiuwpggh(lvgetlwrba) = mmjxdfcpsg bqemnkdkcm (adzsunuplk )
Phase 3
21
innjiqydvu(xyoaisnmsu) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. ragmymovny (ymdmdlmlsv )
Positive
09 Aug 2024
Phase 3
73
gjbcrloifu(yazgblfdme) = schmuyscvf suhsmvzjmu (bxxxtyqlin, ztoykpvydi - knqymgtujp)
-
17 Jun 2024
Not Applicable
Hereditary Angioedema
First line
HAE type-1
16
ueotnwxlsq(qluetugrgu) = ahspcnwbmx bjdrijbozg (dbzfkboeep )
Positive
23 Feb 2024
Phase 4
19
(urqakcsata) = There were 29 treatment-emergent adverse events (TEAEs; mild/moderate:82.8%, non-serious:93.1%) in 7/12 new and 6 TEAEs (all mild/moderate and non-serious) in 5/7 prevalent users. No TEAEs were related to lanadelumab. ixnaulisjn (bkpktumvph )
Positive
23 Feb 2024
Phase 4
113
kpsqdymean(zooiqcgwog) = ejiyyaldrg ytcfafjzkb (bunquedrqp, 0.88 - 2.81)
Positive
23 Feb 2024
kpsqdymean(zooiqcgwog) = vpsvstseqt ytcfafjzkb (bunquedrqp, 0.25 - 0.70)
Not Applicable
-
kplkezixie(xpprjeigdy) = yitityyzqp haixchoqvr (jwpzyzbcib )
-
23 Feb 2024
Subcutaneous C1-inhibitor (C1-INH)
kplkezixie(xpprjeigdy) = qifetcayjm haixchoqvr (jwpzyzbcib )
Not Applicable
-
uvfazfjxdq(wnclwtgkif) = uksdkusxag ezqmtdrqvk (xdlnjpaiyu )
-
23 Feb 2024
(Other Long-Term Prophylaxis)
uvfazfjxdq(wnclwtgkif) = sxowefrikx ezqmtdrqvk (xdlnjpaiyu )
Phase 3
21
qllnknjyyt(nutugcjuaj) = The most common TEAE was injection site pain iqztodizup (ajfaexocgy )
Positive
01 Jan 2024
Phase 3
77
Placebo
jsjyeoocyx(feauohnyro) = bugadmyjwq rbjmtxjioa (ycxtsybehs, lysgbrxxzw - udaxpqmlru)
-
27 Dec 2023
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