FDA Grants Accelerated Approval to Inovio’s VOCERYQ
Inovio Pharmaceuticals’ VOCERYQ received accelerated approval from the U.S. Food and Drug Administration on October 30, 2026. According to the FDA, the treatment, developed as INO-3107, is approved to reduce how often adults with recurrent respiratory papillomatosis, or RRP, need operations to remove papillomas.
RRP produces wart-like growths associated with HPV in the airways, frequently around the larynx and vocal cords. The FDA says surgical removal does not necessarily eliminate the virus from tissue, and patients may need further operations.
The approval rests on a reduction in surgery frequency. The FDA considers that intermediate clinical endpoint reasonably likely to predict clinical benefit, but its approval requires a further study to verify and describe the benefit.
According to the agency, an open-label trial conducted at multiple centers assessed safety and effectiveness in 32 adults. Participants had at least two papilloma-removal operations in the previous 12 months, including one scheduled when they entered the trial. Within a subgroup of 26 participants who had undergone at least three operations before treatment, seven, or 27%, needed no surgery in the first year afterward.
The FDA describes VOCERYQ as the first U.S.-approved immunotherapy based on plasmid DNA. Two plasmids enter cells: one supplies instructions for HPV proteins, while the other carries IL-12, a molecule that enhances immune responses. The agency says the treatment is intended to stimulate immune activity against cells infected by HPV types 6 and 11.
FDA administration instructions specify four injections into muscle, with three weeks between doses. The CELLECTRA 5PSP device delivers brief electrical pulses to help the product enter cells. Among the most frequently reported adverse reactions, the agency lists fatigue, nausea, injection-site reactions, dizziness, headache and high blood pressure.
The required confirmatory study must include at least 50 adults and children with RRP, according to the FDA’s approval letter. Eligibility requires at least three papilloma-related operations during the year before treatment. The study must measure surgery frequency for at least three years following treatment, using an external control or a justified threshold for comparison.
The letter specifies June 30, 2027, as the deadline for submitting the final protocol and August 30, 2032, for the final study report. The approved indication covers adults; the required study population includes children as well.
Investing.com reported that VOCERYQ was Inovio’s first product to receive approval. Inovio said on October 30 that it expected ordering and shipping to begin in about 60 days, with a broader U.S. commercial launch planned for the first quarter of 2027.
* This article is based on publicly available information at the time of writing.