What happened
On 30 October, the US Food and Drug Administration granted accelerated approval to Voceryq, made by Inovio Pharmaceuticals, for adults with recurrent respiratory papillomatosis (RRP). It is the first plasmid DNA-based immunotherapy to be approved in the United States, the FDA said.
RRP is a rare, chronic disease in which human papillomavirus (HPV) types 6 and 11 cause wart-like growths in the airway, most often on the vocal cords. The growths can cause hoarseness, chronic cough and, in severe cases, difficulty breathing. Surgery can remove them, but the virus stays in the tissue, so many patients need repeated operations over many years.
The approval rests on an open-label trial in 32 adults who had needed at least two operations in the previous 12 months. Of the 26 patients who had needed at least three, seven (27%) required no surgery in the first year after treatment, the FDA said. The trial, known as RRP-001, was a phase I/II study, MedPage Today reported.
Why it matters
For people with RRP, every operation carries a risk. ‘The approval of Voceryq is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury,’ said Simon Best of Johns Hopkins University, a trial investigator, in a statement quoted by MedPage Today. Inovio’s chief executive, Jacqueline Shea, told Reuters that every operation carries a risk of permanent vocal cord damage.
Voceryq is designed to tackle the cause rather than the growths. It delivers two small loops of DNA, called plasmids, into muscle cells. One carries instructions for HPV 6 and 11 proteins, so the immune system learns to recognise infected cells; the other carries IL-12, a molecule that strengthens the immune response. It is injected into muscle with a hand-held device that uses brief electrical pulses to help the DNA enter cells. Treatment begins with surgery to remove visible growths, followed by four doses three weeks apart.
Inovio estimates that at least 25,000 people in the US live with RRP, Fierce Pharma reported. The medicine can be kept in a standard fridge with a three-year shelf life, which the company says should allow it to be given in a doctor’s office.
Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it.
Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research
The wider picture
Voceryq is the second medicine approved for RRP. In 2025, Precigen’s Papzimeos became the first, Reuters reported. Both aim to train the immune system against HPV 6 and 11, but Papzimeos uses a modified virus while Voceryq uses DNA, Shea told Reuters. Having two options gives doctors and patients more choice.
In GGND’s view, the approval is also a milestone for DNA medicines more broadly. It is Inovio’s first approved product, and its shares rose 257% in after-hours trading, Reuters said. The road was not smooth: when the FDA accepted the application in March, it said in a preliminary conclusion that Inovio had not submitted adequate information for the accelerated pathway, Fierce Pharma reported.
The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness, the FDA said. The electrical pulses can also cause brief muscle contractions, minor bleeding and light-headedness.
Could it work elsewhere?
RRP occurs worldwide, and HPV 6 and 11 are the same everywhere, so in principle the treatment could help patients in other countries. It would need separate approval from regulators such as those in Europe or the UK. In GGND’s view, the more powerful long-term answer is prevention: HPV vaccines protect against types 6 and 11, and wider vaccination should mean fewer people developing the disease in future.
What remains unresolved
- Strength of the evidence. The trial was small and had no comparison group. Accelerated approval is based on an intermediate measure, fewer operations, that is considered reasonably likely to predict real benefit, so it still has to be confirmed.
- Most patients still needed surgery. About three in four of the most-affected patients still needed at least one operation in the first year, although possibly fewer than before.
- Children. The approval covers adults only. RRP can begin in childhood, when repeated surgery is especially hard, and children are not yet included.
- Price and access. Inovio has not published a price, and it is not yet clear how insurers will cover it.
What happens next
Inovio expects Voceryq to be available to order within about 60 days, with a full launch in the first quarter of 2027, Reuters reported. The confirmatory study will enrol at least 50 adult and paediatric patients and follow them for at least three years. Inovio plans to send a draft protocol to the FDA before the end of 2026 and agree the final design by mid-2027, Fierce Pharma reported.
Sources
- US Food and Drug Administration FDA approves first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis (30 October 2026)
- Reuters US FDA approves Inovio’s treatment for rare throat disease (30 October 2026)
- Fierce Pharma Inovio DNA-based immunotherapy Voceryq approved by FDA for rare HPV airway disease (2 November 2026)
- MedPage Today FDA approves plasmid DNA immunotherapy for recurrent respiratory papillomatosis (October 2026)
Analysis and context are by The GGND Team. Where we draw our own conclusions, we say so. To report an error, contact us.
