FDA grants accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis
On October 30, 2026, the U.S. Food and Drug Administration granted accelerated approval for Voceryq, developed by Inovio Pharmaceuticals, Inc. The biological product is designated for adults living with recurrent respiratory papillomatosis, a rare condition caused by human papillomavirus types 6 and 11. This condition produces persistent, wart-like growths in the human airway that often require repeated surgical removals. Voceryq is the first plasmid DNA-based immunotherapy approved in the United States. It uses small pieces of DNA to help the immune system respond to infected cells. In a clinical trial involving 32 adults, seven out of 26 patients who had at least three prior surgeries required no surgical procedures during their first year following administration. Because the approval is accelerated based on a reduction in surgical frequency, the FDA requires the manufacturer to conduct post-approval trials to confirm long-term clinical benefits.
What was announced
The U.S. Food and Drug Administration granted accelerated approval to Voceryq on October 30, 2026. Manufactured by Inovio Pharmaceuticals, Inc., the biologic is for adults with recurrent respiratory papillomatosis. This rare disease stems from human papillomavirus types 6 and 11, causing small growths in the voice box and respiratory tract.
Voceryq is delivered into muscles using a specialized device called CELLECTRA 5PSP. The device relies on electroporation, a process that sends short electrical pulses into tissues to make cell walls briefly porous. The therapy delivers two bacterial-derived DNA plasmids into cells. One plasmid carries genetic instructions for HPV proteins, while the second carries IL-12, a molecule designed to boost immune responses.
What it means
This decision gives adult patients an option designed to reduce how often they need surgical procedures. People living with recurrent respiratory papillomatosis often undergo repeated operations over many years to clear obstructed airways, as surgery removes the growths but leaves the virus in place.
In an open-label trial with 32 adults, seven out of 26 patients with at least three prior surgeries avoided surgical intervention entirely during the first year after receiving Voceryq. Common side effects include headaches, fatigue, high blood pressure, nausea, dizziness, and injection site reactions. The electroporation delivery method can also cause brief muscle contractions, temporary bleeding, lightheadedness, and local pain.
Because the FDA used its accelerated approval pathway, it accepted reduced surgical frequency as an intermediate signal of clinical benefit. Inovio Pharmaceuticals, Inc. must run post-approval clinical trials to confirm these results.
What the announcement does not tell us
The FDA announcement does not state when Voceryq will become available to patients or how much the dose will cost. It does not provide safety data beyond the initial monitoring period of the trial. The document also does not explain how long the immune response lasts or whether patients will eventually need booster doses. Finally, the announcement leaves out whether post-approval trials are already underway or what specific timeline the FDA set for completing them.
How this was written
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The U.S. Food and Drug Administration today granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for treatment of adults with recurrent respiratory papillomatosis (RRP).
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