The United States Food and Drug Administration (FDA) granted accelerated approval on 30 October to Voceryq, a therapy from Inovio Pharmaceuticals for adults with recurrent respiratory papillomatosis (RRP). The Voceryq approval covers use to reduce the frequency of surgeries in adults with the condition. It is the first plasmid DNA-based immunotherapy approved in the United States, and the first approved product for Inovio.
RRP is caused by human papillomavirus types 6 and 11 (HPV-6 and HPV-11). The virus causes wart-like growths called papillomas in the respiratory tract, and those growths can block the airway and affect the voice. Treatment has relied on repeated surgery to remove the growths, and many patients need several operations over time. The new therapy aims to cut how often those operations are needed.
How the Voceryq approval therapy works
Voceryq, formerly known as INO-3107, is made from two plasmids. One plasmid codes for HPV antigens, and the other codes for interleukin-12 (IL-12). The Voceryq approval covers four doses, one every three weeks, on day 0 and in weeks 3, 6 and 9. Each dose is delivered with the CELLECTRA device, which uses electroporation, a brief electrical pulse that helps cells take up the plasmids.
Patients still need debulking surgery first, to remove existing growths before treatment begins. The therapy is not a replacement for that surgery. Its role, as approved, is to reduce the number of further surgeries a patient needs after the initial debulking.
Trial results behind the Voceryq approval
The Voceryq approval rests on an open-label Phase 1/2 trial in 32 adults. Of those, 26 had undergone three or more surgeries in the prior 12 months. In the 12-month follow-up period, 7 of those 26 patients, or 27 percent, needed no surgery at all. That result formed the basis for the accelerated approval, which allows a drug to reach patients on early evidence while further study continues.
Accelerated approval carries a condition: a confirmatory study must follow. Inovio must submit a draft protocol for that study by the end of 2026 and a final protocol by mid-2027. The confirmatory study will test whether the benefit seen in the early trial holds up in a larger group and over a longer period.
Price and availability after the Voceryq approval
Under the Voceryq approval, the therapy is priced at 115,000 dollars per dose, or 460,000 dollars for the full four-dose course. It is expected to be available in about 60 days from the approval. That price places it among the most expensive therapies for a rare condition, and access will depend on insurance coverage and the arrangements Inovio puts in place with treatment centres.
RRP is a rare condition, and repeated surgery carries its own risks. Each operation on the airway can scar tissue and affect the voice, so reducing the number of operations matters beyond convenience. Patients in the trial had already undergone frequent surgery before enrolment, which is why the follow-up measure focused on how many could go a full year without another operation. Seven of the 26 most heavily treated patients met that mark, and that group is the clearest signal in the early data.
Treatment centres will need the CELLECTRA device to deliver the therapy, since electroporation is part of how each dose is given. That requirement means availability will depend on which centres adopt the device and how quickly they can train staff to use it. Inovio has said the therapy should be available in about 60 days, and the first centres to offer it will likely be those already treating RRP patients with regular surgery.
Voceryq is the second drug approved for RRP, after Precigen’s Papzimeos in 2025. For patients who have lived with repeated airway surgery, the Voceryq approval gives doctors another approach to discuss, alongside surgery alone.
The Voceryq approval applies to adults with recurrent respiratory papillomatosis, for reducing the frequency of surgeries. Further data from the confirmatory study will show how durable the effect is and how many patients can avoid surgery over time.