uniQure seeks FDA priority review for Huntington’s gene therapy AMT-130 BLA - QURE News | RalliesuniQure seeks FDA priority review for Huntington’s gene therapy AMT-130 BLA
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QURE• FDA filing and U.K. application
- uniQure filed a Biologics License Application with the FDA seeking accelerated approval of AMT-130 for Huntington’s disease.
- The company requested priority review, which could cut the FDA review timeline to six months following the 60-day filing review.
- A U.K. marketing authorisation application was also submitted to the MHRA for the same gene therapy.
