Shots:
- The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review
- BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database; 4yr. data analysis from the ongoing P-I/II trials to be presented before the end of the Q3’26
- Based on the same data, the company has also submitted an MAA for ifezuntirgene inilparvovec to the UK MHRA for regulatory review
Ref: Globenewswire | Image: uniQure | Press Release
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