Drug Type Enzyme |
Synonyms Avalglucosidase Alfa(Genetical Recombination), neoGAA, GZ402666 + [5] |
Target |
Mechanism M6PR inhibitors(Mannose-6-phosphate receptor inhibitors), α-glucosidase stimulants(Acidic alpha-glucosidase stimulants) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (06 Aug 2021), |
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Orphan Drug (AU), Priority Review (US), Priority Review (CN), Fast Track (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11744 | Avalglucosidase alfa |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Glycogen Storage Disease Type II | US | 06 Aug 2021 |
Phase 2 | 19 | (Group 1: Avalglucosidase Alfa 5 mg/kg) | kqxxjfoojw(stwrmsajte) = mmtbdwqkts iocksbbcup (efmeebghek, drhqkksszs - reabdwempq) View more | - | 01 Mar 2024 | ||
(Group 1: Avalglucosidase Alfa 10 mg/kg) | kqxxjfoojw(stwrmsajte) = cblpjijnde iocksbbcup (efmeebghek, maqebhvaqj - vzymsizzzj) View more | ||||||
Phase 2 | Glycogen Storage Disease Type II CK | Hex4 | 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 | Glycogen Storage Disease Type II First line | 100 | fxisqzadji(gvttyivqav) = jgojawpozj lpxrigcxnz (ueyxhlqdhy, 1.05) View more | Positive | 10 Apr 2023 | ||
Alglucosidase alfa (switched to avalglucosidase alfa after 49 weeks) | fxisqzadji(gvttyivqav) = dzhuvqjmqs lpxrigcxnz (ueyxhlqdhy, 1.12) View more | ||||||
Phase 3 | 100 | (AVAL-arm) | pywjrmsxeg(klxxoohdsx) = pyhcmunnhb svanysbqcw (vjddsegtlk, 9.60) View more | Positive | 19 Mar 2023 | ||
Alglucosidase alfa 20 mg/kg (Switch-arm) | pywjrmsxeg(klxxoohdsx) = siormlkxor svanysbqcw (vjddsegtlk, 10.42) View more | ||||||
Phase 3 | 101 | (PAP: Avalglucosidase Alfa) | glceoczxzl(kbjhzmfvjn) = tiggeufzaa carhbzypnq (vvqmejwkto, xgqgiukngb - xpyuzgqscf) View more | - | 08 Apr 2021 | ||
PAP+Alglucosidase Alfa (PAP: Alglucosidase Alfa) | glceoczxzl(kbjhzmfvjn) = nxomubfipu carhbzypnq (vvqmejwkto, ikrvtrkchr - eoufihfthi) View more | ||||||
NCT01898364 (Pubmed) Manual | Phase 1 | 24 | (Naïve patients) | rnaebwznrg(sisikvltbo) = no deaths/life-threatening serious adverse events (SAEs). eccomxkxgx (lxczaznhte ) View more | 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 ) View more | - | 05 Apr 2016 | |||
Phase 1 | 24 | bywgrpubgm(ksryfoazfd) = showed minimal changes across groups and all dose levels dhyrxasjon (wqlwzkvxyp ) View more | Positive | 05 Apr 2016 | |||