uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

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 PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease appeared first on PharmaShots.