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FDA Press Releases·

FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis

  • The FDA granted accelerated approval on October 30, 2026, for Voceryq to treat adults with recurrent respiratory papillomatosis (RRP).
  • This approval marks the first plasmid DNA-based immunotherapy authorized in the U.S.
  • Voceryq targets the root cause of RRP caused by HPV types 6 & 11 & aims to reduce the need for repeated surgical interventions.
  • The drug consists of two plasmids containing genetic instructions for HPV proteins & the immune-enhancing molecule IL-12.
  • Administration occurs via intramuscular injection using the CELLECTRA 5PSP Device which utilizes electroporation to deliver the therapy into cells.
  • Clinical trial data showed that 27% of patients with at least three baseline surgeries required no surgery during the first year post-treatment.
  • The accelerated approval is based on the intermediate endpoint of reduced surgical frequency & requires post-approval trials to verify clinical benefit.
  • Common adverse reactions include injection site reactions, headache, fatigue, hypertension, nausea, & dizziness.
  • Electroporation-specific side effects may include muscle contractions, temporary bleeding, anxiety, vasovagal reactions, & skin redness.
  • The FDA awarded Voceryq Breakthrough & Orphan Drug designations & granted the approval to Inovio Pharmaceuticals, Inc.