FDA Grants Accelerated Approval to Inovio's VOCERYQ for Recurrent Respiratory Papillomatosis

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Inovio's VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP). This plasmid DNA-based immunotherapy targets HPV-6 and HPV-11, the primary causes of RRP. The approval is based on demonstrated complete response in a study where patients required no surgical intervention for 12 months after treatment. Inovio plans to make VOCERYQ available in approximately 60 days, with a full commercial launch in the first quarter of 2027.