Quality Issues Star In US FDA Complete Response Letter Trio

 
• By Bridget Silverman
  
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Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

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Three FDA CRLs disclosed this week included manufacturing problems. • Source: Shutterstock

In an unusual move, three US Food and Drug Administration complete response letters related to manufacturing issues were announced in the same week, all relating to very different products: a gene therapy, an antibody-drug conjugate (ADC), and a prodrug/device combination.

Key Takeaways

  • Rocket Pharmaceuticals stressed the limited scope of the Kresladi CRL and its alignment with senior CBER staff.

The CRL for Rocket Pharmaceuticals Inc.’s lentiviral vector-based gene therapy Kresladi (marnetegragene autotemcel) requests “limited additional chemistry manufacturing and...

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