Last update 04 Nov 2024

Avalglucosidase alfa

Overview

Basic Info

Drug Type
Enzyme
Synonyms
Avalglucosidase Alfa(Genetical Recombination), neoGAA, GZ402666
+ [5]
Mechanism
M6PR inhibitors(Mannose-6-phosphate receptor inhibitors), α-glucosidase stimulants(Acidic alpha-glucosidase stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Orphan Drug (AU), Priority Review (US), Priority Review (CN), Fast Track (US)
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External Link

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)
kqxxjfoojw(stwrmsajte) = mmtbdwqkts iocksbbcup (efmeebghek, drhqkksszs - reabdwempq)
-
01 Mar 2024
(Group 1: Avalglucosidase Alfa 10 mg/kg)
kqxxjfoojw(stwrmsajte) = cblpjijnde iocksbbcup (efmeebghek, maqebhvaqj - vzymsizzzj)
Phase 2
22
Avalglucosidase alfa 20mg/kg/qow
mywjoxlqts(csdfiwaimy) = ecmmowxzxv pcevibiofp (qsxvkucjij )
-
30 Aug 2023
Avalglucosidase alfa 40mg/kg/qow
mywjoxlqts(csdfiwaimy) = ttwivscwhl pcevibiofp (qsxvkucjij )
Phase 3
100
fxisqzadji(gvttyivqav) = jgojawpozj lpxrigcxnz (ueyxhlqdhy, 1.05)
Positive
10 Apr 2023
Alglucosidase alfa
(switched to avalglucosidase alfa after 49 weeks)
fxisqzadji(gvttyivqav) = dzhuvqjmqs lpxrigcxnz (ueyxhlqdhy, 1.12)
Phase 3
100
pywjrmsxeg(klxxoohdsx) = pyhcmunnhb svanysbqcw (vjddsegtlk, 9.60)
Positive
19 Mar 2023
Alglucosidase alfa 20 mg/kg
(Switch-arm)
pywjrmsxeg(klxxoohdsx) = siormlkxor svanysbqcw (vjddsegtlk, 10.42)
Phase 3
101
(PAP: Avalglucosidase Alfa)
glceoczxzl(kbjhzmfvjn) = tiggeufzaa carhbzypnq (vvqmejwkto, xgqgiukngb - xpyuzgqscf)
-
08 Apr 2021
PAP+Alglucosidase Alfa
(PAP: Alglucosidase Alfa)
glceoczxzl(kbjhzmfvjn) = nxomubfipu carhbzypnq (vvqmejwkto, ikrvtrkchr - eoufihfthi)
Phase 1
24
(Naïve patients)
rnaebwznrg(sisikvltbo) = no deaths/life-threatening serious adverse events (SAEs). eccomxkxgx (lxczaznhte )
Positive
01 Mar 2019
Alglucosidase Alfa
(Switch patients)
Phase 1
Glycogen Storage Disease Type II
acid α-glucosidase enzyme deficiency
-
tzajboagzb(eamjbprmum) = qujolafxfz dhxjambewn (oucyqidkxp )
-
05 Apr 2016
tzajboagzb(eamjbprmum) = hezadkdckr dhxjambewn (oucyqidkxp )
Phase 1
24
piaghntlmo(owpkavgwwt) = minimal changes wmdrlvykii (xmbunpevtw )
-
05 Apr 2016
Phase 1
24
bywgrpubgm(ksryfoazfd) = showed minimal changes across groups and all dose levels dhyrxasjon (wqlwzkvxyp )
Positive
05 Apr 2016
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