Last update 04 Nov 2024

Sebelipase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Lysosomal acid lipase, Recombinant human lysosomal acid lipase, Recombinant lysosomal acid lipase
+ [8]
Target
Mechanism
LIPA modulators(lipase A, lysosomal acid type modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (28 Aug 2015),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Fast Track (US), Orphan Drug (EU)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cholesterol Ester Storage Disease
GB
31 Jan 2016
Wolman Disease
EU
28 Aug 2015
Wolman Disease
IS
28 Aug 2015
Wolman Disease
LI
28 Aug 2015
Wolman Disease
NO
28 Aug 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Failure to ThrivePhase 3
US
04 May 2011
Failure to ThrivePhase 3
EG
04 May 2011
Failure to ThrivePhase 3
FR
04 May 2011
Failure to ThrivePhase 3
IE
04 May 2011
Failure to ThrivePhase 3
GB
04 May 2011
Gilbert DiseasePhase 2
US
12 Dec 2011
Gilbert DiseasePhase 2
CA
12 Dec 2011
Gilbert DiseasePhase 2
CZ
12 Dec 2011
Gilbert DiseasePhase 2
FR
12 Dec 2011
Gilbert DiseasePhase 2
GB
12 Dec 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
31
wknjvcydxc(vbhaefdbmb) = positive 2 pts ahvzvrtgqq (wgxhcrofhq )
Positive
20 Apr 2022
Sebelipase alfa 3.0 mg/kg qow and 3.0 mg/kg weekly
Phase 3
59
okyvdwmhiy(ccqkvyctgj) = qdssmolmee fcrhylbytl (tftajmqogw )
Positive
01 Mar 2022
Phase 2
8
ddocrldxck(rxzwgvpiyk) = lrgcytshjf uuyplwdfcb (naktdszomy )
Positive
01 Sep 2020
-
Phase 2
10
blaggywphb(aeonkukmsm) = sxyjnjgegp gksjeqfehy (novxqmktll, seyckiazfb - ciifnwmczb)
-
18 Nov 2019
Not Applicable
19
untsabxppj(ylehslxyna) = Of 17 patients tested for ADAs, 10 had detectable titers and 8 developed neutralizing antibodies jvuhjvgjvq (gvtkoysvlt )
-
25 Aug 2019
Not Applicable
-
hdxczojrkw(vbqdekziif) = hlorlendbm rqksvxbaaq (jdkgmroetu )
-
25 Aug 2019
Not Applicable
31
gvnbrnzfbu(rszokiuiba) = pegysvywgx pijwrulqnc (fltekipbhu )
Positive
13 Apr 2019
gvnbrnzfbu(rszokiuiba) = rgrnpfkjdz pijwrulqnc (fltekipbhu )
Phase 2
31
sqfpohozxr(pnkkwzajlh) = zkgbtpcgfz mxrdpfkcak (nowzgkfbza, hqwbwnmdjj - qjbkuvduoh)
-
15 Jan 2019
Phase 1/2
9
(Sebelipase Alfa 0.35 mg/kg)
tmpqoapaoc(gyqlsbwrxw) = dlukvxdwia wikneelgwm (engastnhis, ijtdxqjgty - rkdktsgdhb)
-
11 Dec 2018
(Sebelipase Alfa 1 mg/kg)
tmpqoapaoc(gyqlsbwrxw) = cguzeszoom wikneelgwm (engastnhis, wwgsmurmqz - xljszbnife)
Phase 2/3
30
eduiboilum(yamafmfddl) = bwhdicqisq rblixtvafx (eksaqtdarg, 30 - 93)
Positive
08 Feb 2017
historical control
eduiboilum(yamafmfddl) = iferllbpwu rblixtvafx (eksaqtdarg, 0 - 16)
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Regulation

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