RealFeedApp FDA reversed earlier opposition to uniQure's BLA for gene therapy
The FDA established a May 1 PDUFA action date for uniQure's candidate ifezuntirgene inilparvovec. This therapy aims to be the first treatment to modify the fatal, inherited neurodegenerative disorder.
- Field
- gene therapy
- What they did
- The FDA has set a May 1 deadline to review uniQure's gene therapy candidate ifezuntirgene inilparvovec, which could become the first treatment to modify the fatal, inherited neurodegenerative disorder.
- Why it matters
- This marks a complete reversal of the FDA's previous opposition to the drug after the company submitted its Biologics License Application under Priority Review.
#huntington's disease#gene therapy#fda approval#uniqure#ifezuntirgene
