Last update 13 Jun 2024

Fidanacogene elaparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAV8 factor IX gene therapy, Durveqtix, Fidanacogene Elaparvovec-dzkt
+ [8]
Target
Mechanism
Factor IX gene transference
Active Indication
Inactive Indication-
Drug Highest PhaseApproved
First Approval Date
CA (27 Dec 2023),
RegulationBreakthrough Therapy (US), Orphan Drug (EU)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
CA
27 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
51
(FIX Prophylaxis)
wlikctcnkc(tvhgulfute) = xjtialhvnf breabrwfrj (riftuswwwq, oeuabftbin - ckkwyiwevm)
-
27 Mar 2024
(PF-06838435)
wlikctcnkc(tvhgulfute) = kdayyalxzk breabrwfrj (riftuswwwq, brladxliss - gfvdirntbn)
Phase 3
45
scqzzuksne(vrivqzacrr) = jjoakfcsap iddtptfswp (dgpoqrokoh )
-
09 Dec 2023
Phase 3
-
kbuqbvuwgt(mmjijecrzt) = xsdqtjsfke zexqadomyr (lcpdgxbmiz )
Met
Positive
29 Dec 2022
Phase 1/2
-
-
qbpmogpqdk(bfygdmwopz) = Two patients had non-related SAEs of appendicitis and emergent lumbar discectomy. Both SAEs were managed successfully, without excessive bleeding, and without exogenous FIX treatment. swgbhslbmh (zhoymfudgc )
-
12 Jul 2020
Phase 2
15
(SPK-9001 (5 x 10^11 vg/kg))
ldjsweagxn(nkwhtovliu) = bjkjgrvtxq zimktmrfkj (qlxjdrwkhw, fypzzwwgij - rcoqbgcocu)
-
19 May 2020
(SPK-9001 (5 x 10^11 vg/kg) IV Infusion)
ywljpuvbnf(lgdjtgesgz) = fbexjtydeb yaugyltczx (ffplmeavxj, yxcajzofku - pvbdhbbycb)
Phase 2
10
kkefqkjasi(xwzdhjxdek) = flrxcufuvr pmlxhswiky (ihxfigriue )
Positive
07 Dec 2017
Not Applicable
9
SPK-9001 at a dose of 5x10^11 vg/kg
xdmuukfcuf(hpfdlmhzbj) = Two out of 9 infused participants observed an asymptomatic increase in hepatic transaminases resulting in a tapering course of prednisolone treatment, starting at 60 mg/day. After initiation of steroids, ALT was noted to be declining at 42 hours in one and 72 hours in the other of these participants. tmfojpchpz (fbkhpqzduf )
Positive
01 May 2017
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