The US Food and Drug Administration (FDA) has granted accelerated approval to Voceryq, a new treatment aimed at reducing repeat surgery for adults with recurrent respiratory papillomatosis. This rare disease causes growths in the airways, affecting the voice and, in severe cases, breathing. The FDA announced the decision on October 30, describing Voceryq as the first plasmid DNA-based immunotherapy approved in the United States.
Voceryq is not the first immunotherapy for this condition; the FDA approved Papzimeos, which uses a different technology, in August 2025. The approval of Voceryq does not establish a cure and requires further clinical trials to confirm its clinical benefit. The FDA's decision was based on an open-label study involving 32 adults with recurrent respiratory papillomatosis.
In the study, 26 participants who had needed at least three surgeries in the preceding 12 months were evaluated. Among these, seven, or 27%, required no surgery during the first year after treatment. This result supported the accelerated approval, a route that allows earlier access based on an intermediate measure considered likely to predict clinical benefit.
Recurrent respiratory papillomatosis is associated with HPV types 6 and 11. While surgery can remove the growths, they can return, necessitating repeated surgical interventions. Voceryq's approval offers a new treatment option for patients suffering from this condition, potentially reducing the need for repeat surgeries.
The manufacturer, Inovio, expects orders and shipments of Voceryq to begin in approximately 60 days, with full commercial deployment anticipated in the first quarter of 2027. The company must submit a draft protocol for a confirmatory study by the end of 2026, with a final protocol expected to be agreed upon by mid-2027.
Inovio has identified several common adverse reactions associated with Voceryq, including injection-site reactions, headache, fatigue, high blood pressure, nausea, and dizziness. The treatment uses Inovio's Cellectra delivery device, which applies electrical pulses to help deliver the medicine into cells.
The approval of Voceryq concerns US authorization only, and announcements do not establish South African approval or local availability. Inovio also warns of potential delivery-related side effects, such as muscle contractions, bleeding, and vasovagal reactions, which can cause faintness or fainting.
Key points
- Voceryq is the first plasmid DNA-based immunotherapy approved in the US for treating recurrent respiratory papillomatosis.
- The FDA's approval was based on an open-label study showing 27% of participants required no surgery during the first year after treatment.
- Further clinical trials are required to confirm Voceryq's clinical benefit.
