FDA Grants Accelerated Approval to First Plasmid DNA-Based Immunotherapy for Recurrent ...

The FDA has granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), the first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis, a rare airway disease caused by HPV-6 and HPV-11. Clinical trials showed significant reduction in required surgeries, and the therapy offers a new treatment approach distinct from viral vector-based options.

This Wire brief sits within Fusion42's coverage of Biotech, and 5 sources have reported it.