Rocket Reports the US FDA Acceptance of BLA for RP-L201 (marnetegragene autotemcel) to Treat Severe Leukocyte Adhesion Deficiency-I
Shots:
- The US FDA has accepted the BLA & granted Priority Review for RP-L201 to treat sev. LAD-I. The US FDA decision is expected on March 31, 2024
- The P-I/II study results showed that the patient achieved overall survival (100%) at 12mos. post-infusion for 9 LAD-I patients with 12-24mos. follow-up, reduction in incidences of significant inf. with evidence of resolution of LAD-I-related skin lesions and restoration of wound repair capabilities over pre-treatment history, was well tolerated with no treatment-related SAEs
- RP-L201 is a lentiviral vector (LV)-based investigational gene therapy & received US FDA’s Regenerative Medicine Advanced Therapy, Rare Pediatric, FTD & ODD. The company is also eligible for a Priority Review Voucher if RP-L201 is approved
Ref: Businesswire | Image: Rocket
Related News:- Rocket Presents Results of RP-L201 in the P-II Trial for the Treatment of Severe Leukocyte Adhesion Deficiency-I at ASGCT 2022
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