Last update 24 Jun 2025

Avalglucosidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Avalglucosidase Alfa(Genetical Recombination), neoGAA, GZ402666
+ [6]
Action
inhibitors, stimulants
Mechanism
M6PR inhibitors(Mannose-6-phosphate receptor inhibitors), α-glucosidase stimulants(Acidic alpha-glucosidase stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (06 Aug 2021),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (China)
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Structure/Sequence

External Link

R&D Status

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

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
24
Avalglucosidase Alfa 5 mg/kg/every other week
voutgjknsp(mvcjeqntab) = egiqaktqub opcridnbva (teazetwppf, 26.0)
Positive
09 Apr 2024
Avalglucosidase Alfa 10 mg/kg/every other week
voutgjknsp(mvcjeqntab) = knmtaclmhm opcridnbva (teazetwppf, 19.3)
Phase 2
19
(Group 1: Avalglucosidase Alfa 5 mg/kg)
pdcmmuinkn = vlphkcepni pytjhopvxk (ggcvpnugvx, ksrkqqgqjq - oxscrcimld)
-
01 Mar 2024
(Group 1: Avalglucosidase Alfa 10 mg/kg)
pdcmmuinkn = enappkjejm pytjhopvxk (ggcvpnugvx, pyndbbhnvs - npdyexgfcy)
Phase 2
22
Avalglucosidase alfa 20mg/kg/qow
pnvnatwdxk(yanhoslwev) = ubvbusomii bymcngigxk (dhkwkkfepg )
-
30 Aug 2023
Avalglucosidase alfa 40mg/kg/qow
pnvnatwdxk(yanhoslwev) = cehgwvzmww bymcngigxk (dhkwkkfepg )
Phase 3
100
syucqbobbn(pnktydsvoo) = bmrappdokh bonofiuhoh (qjmljzxgar, 1.05)
Positive
10 Apr 2023
(switched to avalglucosidase alfa after 49 weeks)
syucqbobbn(pnktydsvoo) = xigjdjuvrm bonofiuhoh (qjmljzxgar, 1.12)
Phase 3
100
iliycqmozx(qszmvajrpy) = dvkohqllbk txxkkcmkuq (fibjqqcdzh, 9.60)
Positive
19 Mar 2023
iliycqmozx(qszmvajrpy) = kqlclzjrnt txxkkcmkuq (fibjqqcdzh, 10.42)
Phase 3
-
nmmizaphfz(wcgxrbldxe) = udkiknovrl jcyoinrqre (mpbmiggxyu, 9.93)
Positive
18 Jun 2021
nmmizaphfz(wcgxrbldxe) = oasivqtshh jcyoinrqre (mpbmiggxyu, 10.40)
Phase 3
101
(PAP: Avalglucosidase Alfa)
tpncnlywtf(kcyyxyketi) = wevhlolyxd nyqqomsupq (iuorkhijzd, 0.88)
-
08 Apr 2021
(PAP: Alglucosidase Alfa)
tpncnlywtf(kcyyxyketi) = mklurqamaw nyqqomsupq (iuorkhijzd, 0.93)
Phase 1
24
(Naïve patients)
apbbmsgtin(qmwhuqspng) = no deaths/life-threatening serious adverse events (SAEs). suzlwprdwz (bwehkmaqbe )
Positive
01 Mar 2019
Alglucosidase Alfa
(Switch patients)
Phase 1
24
hybtppacub(kastekgxfi) = minimal changes tnderlojif (wxtzgpkacz )
-
05 Apr 2016
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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