For some patients, the operating theatre becomes a routine appointment. Recurrent respiratory papillomatosis, a rare disease caused by two strains of the human papillomavirus, grows wart-like tumours in the airways. They come back, again and again, and each time they must be cut out — sometimes dozens of times over a lifetime, each surgery carrying its own risk to the voice and the airway.
On Friday, the US Food and Drug Administration approved the first treatment designed to break that cycle at its root. VOCERYQ, made by the biotechnology company INOVIO, is a plasmid DNA immunotherapy: instead of removing the growths, it teaches the patient’s own immune system to attack the virus that causes them.
The approval is a first in a specific sense. It is the first DNA medicine — a treatment built from engineered circles of DNA called plasmids — to be approved in the United States. DNA medicines have been in development for more than three decades, and until now none had crossed the finish line.
Here is how it works. VOCERYQ contains two plasmids. One carries the genetic code for proteins from HPV types 6 and 11, the strains behind most cases of the disease. The other carries the code for interleukin-12, a molecule that rallies the immune response. The plasmids are injected into muscle, and a handheld device called CELLECTRA 5PSP delivers a brief electrical pulse — electroporation — that briefly opens the muscle cells so the DNA can get inside. The cells then produce the viral proteins, and the immune system learns to recognise and attack cells carrying them.
The evidence comes from a small trial, and the numbers deserve a plain reading. In the RRP-001 study, 32 adults took part, all of whom had needed at least two surgeries in the previous year. Among the 26 patients who could be fully assessed, seven — 27% — needed no surgery at all in the 12 months after treatment. That is the result on which the FDA granted accelerated approval: a meaningful gain for a minority, not a cure for everyone.
Accelerated approval is the FDA’s way of saying “promising, but prove it.” INOVIO must run a confirmatory study, with a draft protocol due to the FDA by the end of 2026 and a final design expected by mid-2027. The company expects the treatment to be available to order in about 60 days, with a full launch in the first quarter of 2027.
Why does a drug for a rare throat disease matter beyond its patients? Because the platform matters more than the product. If a DNA medicine can clear regulators once, the same approach — swap in a different genetic code — can be aimed at other HPV diseases and at cancers driven by the virus. INOVIO’s own pipeline, and those of its rivals, will now be judged against a real approval rather than a promise. Further reading: how mRNA vaccines taught the body to defend itself and personalised cancer vaccines.
There is a second comparison worth making. Last year, a different treatment for the same disease, Papzimeos, became the first medicine approved for it — but it uses a modified virus to deliver its payload. VOCERYQ uses no virus at all, just DNA and an electrical pulse. For patients, the difference that counts is simpler: fewer trips to surgery, and a voice that survives intact.
