US approves Voceryq to reduce repeat surgery for rare airway disease

US regulators have granted accelerated approval to Voceryq, a new treatment intended to reduce repeat surgery for adults with recurrent respiratory papillomatosis, a rare disease that causes growths in the airways.

The Food and Drug Administration announced the decision on Friday, 30 October. It described Voceryq as the first plasmid DNA-based immunotherapy approved in the United States.

It is not the first immunotherapy for this condition: the FDA approved Papzimeos, which uses a different technology, in August 2025.

The approval does not establish a cure. The FDA requires further clinical trials to confirm the treatment’s benefit.

What the evidence shows

The FDA said its decision drew on an open-label study involving 32 adults. Among 26 participants who had needed at least three surgeries in the preceding 12 months, seven — 27% — required no surgery during the first year after treatment.

The result supported accelerated approval, a route that allows earlier access based on an intermediate measure considered likely to predict clinical benefit. It is not the same as completing the required confirmatory research.

Recurrent respiratory papillomatosis is associated with HPV types 6 and 11. Growths can affect the voice and, in severe cases, breathing. Surgery removes the growths, but they can return.

Launch remains ahead

Manufacturer Inovio said in a statement issued on Friday evening in the US that it expects orders and shipments to begin in approximately 60 days, with full commercial deployment in the first quarter of 2027. These are company forecasts, not confirmation that the medicine is already available.

Inovio said it must submit a draft protocol for a confirmatory study by the end of 2026, with a final protocol expected to be agreed by mid-2027.

The company lists injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among the most common adverse reactions. Treatment uses its Cellectra delivery device, which applies electrical pulses to help deliver the medicine into cells.

The company also warns of delivery-related muscle contractions, bleeding and vasovagal reactions, which can cause faintness or fainting.

The decision concerns US authorisation. The announcements do not establish South African approval or local availability.