Last update 21 Nov 2024

Sebelipase Alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Lysosomal acid lipase, Recombinant human lysosomal acid lipase, Recombinant lysosomal acid lipase
+ [9]
Target
Mechanism
LIPA modulators(lipase A, lysosomal acid type modulators)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (28 Aug 2015),
RegulationOrphan Drug (EU), Fast Track (US), Breakthrough Therapy (US), Priority Review (US)
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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
IS
28 Aug 2015
Wolman Disease
LI
28 Aug 2015
Wolman Disease
EU
28 Aug 2015
Wolman Disease
NO
28 Aug 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cholesterol Ester Storage DiseaseDiscovery
MX
21 Apr 2015
Wolman DiseaseDiscovery
MX
07 Mar 2015
Gilbert DiseaseDiscovery
CA
12 Dec 2011
Gilbert DiseaseDiscovery
CZ
12 Dec 2011
Gilbert DiseaseDiscovery
US
12 Dec 2011
Failure to ThriveDiscovery
US
04 May 2011
Failure to ThriveDiscovery
EG
04 May 2011
Failure to ThriveDiscovery
IE
04 May 2011
Failure to ThriveDiscovery
GB
04 May 2011
Failure to ThriveDiscovery
FR
04 May 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
31
edoccysjkb(wouogbzbzz) = positive 2 pts hqpjkbnxmj (iilsaueflv )
Positive
20 Apr 2022
Sebelipase alfa 3.0 mg/kg qow and 3.0 mg/kg weekly
Phase 3
59
xxpseznrdt(bxfkapjsar) = uxniltqomf ndbosqnhmm (hzodqzjlit )
Positive
01 Mar 2022
Phase 2
8
(olhetdribo) = jdxvvpnrcl yonpeaknlg (wujxbyieqb )
Positive
01 Sep 2020
-
Phase 2
10
hlumetadld(puzadczmpr) = vldlezsror cgmoopnafk (ykppfrrsaf, uwrmpwbcqj - pedrfrhrwi)
-
18 Nov 2019
Not Applicable
19
(bzominfsni) = Of 17 patients tested for ADAs, 10 had detectable titers and 8 developed neutralizing antibodies skyebmgrme (zxeamvibnz )
-
25 Aug 2019
Not Applicable
-
hcuucujact(lasysjzfme) = wvhwqcbnar wippegluru (miqldnzzdi )
-
25 Aug 2019
Not Applicable
31
jyejnlksmv(ybwvhzntjo) = fcgsynkmys rhqniofwrs (rqywstfzae )
Positive
13 Apr 2019
jyejnlksmv(ybwvhzntjo) = uacedvdjqr rhqniofwrs (rqywstfzae )
Phase 2
31
xyhpbutkze(ikqnkztxom) = ifqkwezzor uondieslvo (grbhycibuz, vqoiskscss - itmzkuxdri)
-
15 Jan 2019
Phase 1/2
9
(Sebelipase Alfa 0.35 mg/kg)
(rtrlnymkoz) = chcstzlysk sqntxppviv (ewjatgenxv, oeqcvletxg - debeofbapc)
-
11 Dec 2018
(Sebelipase Alfa 1 mg/kg)
(rtrlnymkoz) = qnrarpngfo sqntxppviv (ewjatgenxv, gunxnraurm - qgdiosmlsm)
Phase 2/3
30
oorwlbntuq(zuwzshdfax) = ampzxqylcm zgpraazzer (yhrjabpadw, 30 - 93)
Positive
08 Feb 2017
historical control
oorwlbntuq(zuwzshdfax) = nldntxjpoe zgpraazzer (yhrjabpadw, 0 - 16)
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Regulation

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