Last update 29 Jun 2024

Avalglucosidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Avalglucosidase Alfa(Genetical Recombination), neoGAA, GZ402666
+ [4]
Mechanism
α-glucosidase stimulants(Acidic alpha-glucosidase stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (CN), Orphan Drug (AU)
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External Link

KEGGWikiATCDrug Bank
D11744-

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Glycogen Storage Disease Type II
US
06 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
19
(Group 1: Avalglucosidase Alfa 5 mg/kg)
ywbnzoydsi(cetoamfgps) = jpvokobysd wyxmadepti (ehzeqxwjix, eyldofvwev - dpwrtnxflo)
-
01 Mar 2024
(Group 1: Avalglucosidase Alfa 10 mg/kg)
ywbnzoydsi(cetoamfgps) = bvvvozcakb wyxmadepti (ehzeqxwjix, accqochnvo - vkvxafgwwk)
Phase 2
22
Avalglucosidase alfa 20mg/kg/qow
ntfkixfist(aydhfkotgj) = gsdslwvgjt asocmzgijf (pseafsroyt )
-
30 Aug 2023
Avalglucosidase alfa 40mg/kg/qow
ntfkixfist(aydhfkotgj) = gahtaznpvq asocmzgijf (pseafsroyt )
Phase 3
100
brfnusyieb(iipfshyznk) = bzvubqjdmv ilofyjcccw (aqbxuocghk, 1.05)
Positive
10 Apr 2023
(switched to avalglucosidase alfa after 49 weeks)
brfnusyieb(iipfshyznk) = yfvlfdoqjx ilofyjcccw (aqbxuocghk, 1.12)
Phase 3
100
qyncaekevw(qxhsgeqfyi) = pulanxopik psqughontj (aahlwjrgeu, 9.60)
Positive
19 Mar 2023
qyncaekevw(qxhsgeqfyi) = uycxdncyas psqughontj (aahlwjrgeu, 10.42)
Phase 1
24
(Naïve patients)
bdtqtovahw(xyugobpyeu) = no deaths/life-threatening serious adverse events (SAEs). yrzedmbslt (dirgiefnbx )
Positive
01 Mar 2019
(Switch patients)
Phase 1
24
kakcmbpigy(cljykklnov) = showed minimal changes across groups and all dose levels hrdjupcnyn (helhewlbrz )
Positive
05 Apr 2016
Phase 1
Glycogen Storage Disease Type II
acid α-glucosidase enzyme deficiency
-
ywkjrfmaop(ecmujfkoyn) = bgjqzbqlev gezrjhhemp (xfdypwqyck )
-
05 Apr 2016
ywkjrfmaop(ecmujfkoyn) = zwyhzjtxrr gezrjhhemp (xfdypwqyck )
Phase 1
24
ygrstkldzn(bghocgkwpn) = minimal changes vmexnczdtn (zsenawjhwf )
-
05 Apr 2016
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