FDA Grants Accelerated Approval to Voceryq for Recurrent Respiratory Papillomatosis
November 2, 2026
The US Food and Drug Administration granted accelerated approval to Voceryq for recurrent respiratory papillomatosis in adults on October 30, 2026. It is the first plasmid DNA-based immunotherapy approved in the United States. The approval went to Inovio Pharmaceuticals.
Recurrent respiratory papillomatosis (RRP) is a rare, chronic disease caused by human papillomavirus (HPV) types 6 and 11. Wart-like growths called papillomas form in the airway, most often on the vocal cords, and cause hoarseness, chronic cough and, in severe cases, difficulty breathing. Surgery removes the growths but not the virus, so patients often need repeated procedures over many years.
Trial data behind Voceryq for recurrent respiratory papillomatosis
Voceryq delivers two plasmids into the body’s cells. One carries the genetic instructions for HPV proteins and the other for IL-12, a molecule that boosts the immune response, so that the immune system attacks infected cells. It is given by intramuscular injection with the CELLECTRA 5PSP Device, which uses brief electrical pulses to get the plasmids into cells.
The FDA based its decision on an open-label multicenter trial in 32 adults who had needed two or more surgeries in the 12 months before treatment. Of the 26 patients with at least three baseline surgeries, seven (27%) needed no surgery in the first year after treatment. The most common adverse reactions were injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Voceryq also holds Breakthrough and Orphan Drug designations.
Why it matters
The approval rests on fewer surgeries, which the FDA treats as an intermediate endpoint reasonably likely to predict clinical benefit. That is how the accelerated approval pathway works, and Inovio must now run post-approval trials to confirm the benefit. The release reports the surgery-free rate only for the 26 patients with the heaviest surgical history and describes no control arm, so the 27% figure has no comparator yet. For payers, the case so far is a therapy aimed at the virus rather than the growths, backed by evidence the FDA itself still treats as provisional.
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