FerringJapanannouncesPMDAAcceptanceofNDAFilingfornadofaragenefiradenovec
===2025-9-12 9:51:15===
发布时间:2025-09-12 09:28
Nadofaragene firadenovec is the first and only non-replicating gene therapy administered intravesically, and it is already approved and launched in the US
This represents the first filing of a novel non-chemotherapy approach in non-muscle invasive bladder cancer (NMIBC) treatment
In the Japanese Phase 3 clinical trial, 75% complete response rate was achieved with single quarterly dosing, without requiring re-induction protocols1
This acceptance highlights Ferrings ongoing commitment to establish the new standard of care for BCG-unresponsive NMIBC
SAINT PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals Co., Ltd. announced that the PMDA has accepted the NDA for nadofaragene firadenovec for review, following submission on August 27th, 2025. This non-replicating gene therapy, administered intravesically, offers patients with NMIBC a bladder-sparing treatment option. Nadofaragene firadenovec's quarterly dosing eliminates the burd
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