Good newsFDA Approves First Plasmid DNA Immunotherapy to Cut Surgeries in Rare Airway Disease
The US drugs regulator granted accelerated approval to Voceryq on 30 October for adults with recurrent respiratory papillomatosis. In a 26-patient efficacy group, 7 needed no surgery for a year. A confirmatory trial is required.
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Adults with a rare, HPV-driven airway disease now have a second medicine that aims to spare them repeated surgery. On Friday 30 October the US Food and Drug Administration granted accelerated approval to Voceryq, made by INOVIO, for recurrent respiratory papillomatosis (RRP). The FDA says it is the first plasmid DNA-based immunotherapy approved in the US.
The evidence is early. The approval rests on one open-label phase 1/2 trial in 32 adults, and INOVIO’s release reports no comparison with a control group. A confirmatory study is required. This piece sets out what the trial showed, who could use the drug, and what is still unknown.
What the disease does
RRP is caused by human papillomavirus types 6 and 11. The virus makes wart-like growths, called papillomas, in the airway, most often around the vocal cords. They cause hoarseness, chronic cough and voice changes, and in severe cases they spread and make breathing difficult. In some cases the growths become cancerous over time, the FDA says.
Surgery removes the growths but does not remove the virus, so they tend to come back. Patients can need procedures repeatedly over many years. INOVIO says every operation carries a risk of permanent damage to the vocal cords. The company estimates that at least 25,000 people in the US live with the disease. The FDA put new diagnoses at about 1,000 a year when it approved the first RRP therapy last year.
How the drug works
Voceryq delivers two small rings of DNA, called plasmids, into the body’s cells. One carries the genetic instructions for HPV-6 and HPV-11 proteins. The other encodes IL-12, a molecule that boosts the immune response. The aim is to train the immune system to attack cells infected with those two HPV types.
It is given as an injection into the muscle with a device called CELLECTRA 5PSP. The device uses brief electrical pulses to open pores in cell membranes for a moment, which lets the DNA in. The FDA approved the drug together with that device.
What the trial found
The trial, called RRP-001, enrolled 32 adults who had at least two papilloma operations in the previous 12 months. Twenty-six of them had three or more, with a median of 4.5 and a range of 3 to 8. Those 26 form the efficacy group.
Seven of the 26, or 27%, needed no surgery to remove papillomas in the 12 months of follow-up, according to INOVIO’s release. The 95% confidence interval runs from 12% to 48%. The company says that result is not expected in untreated disease. The other 19 still needed some surgery.
Chart: GoodBad. Data from INOVIO’s release of 30 October 2026 (company-reported), trial RRP-001.
The company says the full results were published in Nature Communications and The Laryngoscope. The company also says no extra surgery was required during the dosing window itself.
Side effects
INOVIO reports that the drug was well tolerated. The most common side effects, seen in more than 5% of patients, were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. Most treatment-related reactions were mild or moderate and short-lived. There were no grade 4 or 5 events, and all 32 patients completed the study.
Why it was approved on this evidence
Accelerated approval lets the FDA clear a medicine for a serious condition on an intermediate measure that is reasonably likely to predict real benefit. Here the measure is fewer surgeries. The manufacturer must run post-approval trials to verify and describe the clinical benefit, and continued approval may depend on them.
INOVIO says the FDA requires a draft protocol for the confirmatory study by the end of 2026. It expects to agree a final protocol by mid-2027. The FDA’s director of its biologics centre, Karim Mikhail, said the approval could mean “fewer surgeries, fewer disruptions, and more time living their lives”.
Does this affect me?
For most people, no: RRP is rare. For the people it does affect, a second option widens the choice. Papzimeos, an adenoviral vector therapy given by injection under the skin, was approved in August 2025. The FDA said then that no approved medical therapy existed to remove the need for repeated surgery.
The two approvals differ in design, and none of the sources compares them head to head. Price has not been announced either. INOVIO expects Voceryq to be available to order and ship in about 60 days, and expects full commercial launch in the first quarter of 2027.
What to watch
Three things will show whether the early signal holds. The first is the design of the confirmatory trial, which will show whether a control group is used. The second is longer follow-up of the same patients. The third is the label and price when the drug ships around the turn of the year. How it compares with the first approved therapy depends on all three.
Until then, the honest summary is modest and real. A regulator has accepted that a DNA medicine can act on an airway virus, and 7 of 26 patients went a year without an operation they had been having several times a year.
