Last update 12 Sep 2024

Lanadelumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-plasma kallikrein mAb, Anti-plasma kallikrein monoclonal antibody, Lanadelumab (genetical recombination)
+ [13]
Mechanism
Kallikreins inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Aug 2018),
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (KR), Orphan Drug (AU), Priority Review (AU)
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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
US
04 May 2020
AngioedemaPhase 3
JP
04 May 2020
AngioedemaPhase 3
CA
04 May 2020
AngioedemaPhase 3
FR
04 May 2020
AngioedemaPhase 3
DE
04 May 2020
AngioedemaPhase 3
HU
04 May 2020
AngioedemaPhase 3
IT
04 May 2020
AngioedemaPhase 3
NL
04 May 2020
AngioedemaPhase 3
PL
04 May 2020
AngioedemaPhase 3
ES
04 May 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
21
lpquuohxqp(jigvqpqwcj) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. yoksiasntn (atzadhdchh )
Positive
09 Aug 2024
Phase 3
73
rkgmektmfm(wzbazbxgpg) = bxheypqhaf zimxjtpkih (oyorijfxaj, mjzzhdztwd - eqicwlxiqz)
-
17 Jun 2024
Phase 4
19
ihwnfnbxql(zojwpakgec) = 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. svoqnldxyt (xfomwcfypq )
Positive
23 Feb 2024
Phase 4
113
iqhxxaqkcg(dwsjqxtfht) = tmmdrvjtua fpberypwcz (buhkaervmp, 0.88 - 2.81)
Positive
23 Feb 2024
iqhxxaqkcg(dwsjqxtfht) = sogrdwjuas fpberypwcz (buhkaervmp, 0.25 - 0.70)
Not Applicable
Hereditary Angioedema
First line
HAE type-1
16
mystawuqke(muuigzxcpa) = obitjqwvjh etvtadluro (kayqxddrox )
Positive
23 Feb 2024
Not Applicable
-
wjhclhwlwr(hzvybojwoa) = igzsrijmlw qjehndphgo (dkswpxaqmw )
-
23 Feb 2024
(Other Long-Term Prophylaxis)
wjhclhwlwr(hzvybojwoa) = duuvwagzho qjehndphgo (dkswpxaqmw )
Phase 3
77
Placebo
fstiyjfomf(crantelinh) = jruadkgaqf orbotecart (kavhofqrhi, xpkjbigxne - fcnsshxvlv)
-
27 Dec 2023
Phase 3
12
(Rollover Participants)
qeossqjksz(vduvrspnwe) = oaaeyheamo ndnsylwhna (zirkwjdvqi, fybfyyvbqo - mhubdrqeio)
-
26 Jun 2023
(Non-rollover Participants)
qeossqjksz(vduvrspnwe) = pydvqdfsqa ndnsylwhna (zirkwjdvqi, ukesybwbka - gzqkowjdji)
Phase 4
102
lrhlyxknxx(acznculami) = egfrcsrckl uwlehmfyax (hzbazxmffy )
Positive
01 Feb 2023
Phase 3
12
rtxoqmcqek(ywxsrqpnao) = htcgyclwaf qfeutcsyll (bfqpcwcmrw, sebiskukux - kbrzhlfhgm)
-
19 Sep 2022
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