FDA grants accelerated approval to Inovio’s VOCERYQ for rare HPV-related airway disease

On October 30, 2026, the FDA granted accelerated approval to Inovio’s VOCERYQ (formerly INO-3107) to reduce the frequency of surgical papilloma removal in adults with recurrent respiratory papillomatosis (RRP).

RRP is a rare, chronic disease usually associated with HPV-6 or HPV-11. It causes wart-like growths in the airways that can return after surgery and may affect speaking or breathing.

VOCERYQ is a plasmid DNA-based immunotherapy designed to prompt an immune response against HPV-6 and HPV-11. It is the first FDA-approved plasmid DNA-based immunotherapy, according to the FDA and Inovio.

The approval relied on the RRP-001 study. In the FDA’s efficacy group of 26 patients, 7 (27%) went 12 months without another surgical excision.

The approval is conditional under the FDA’s accelerated-approval pathway:
Inovio must conduct a confirmatory study to verify clinical benefit. Inovio said it expected ordering and shipping to begin in about 60 days, with a broader launch planned for Q1 2027.

Sources:

News Details

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