The FDA has approved Voceryq, a DNA-based immunotherapy developed by Inovio Pharmaceuticals, for treating adults with recurrent respiratory papillomatosis (RRP). This condition, driven by HPV-related growths in the airway, has historically required repeated surgeries for management. The treatment works by combining two DNA plasmids with electroporation, a brief electrical pulse, to activate the immune system against infected cells.
The approval included two postmarketing requirements. The FDA directed Inovio to reexamine human factors testing for the Cellectra 5PSP, the device used to deliver Voceryq. Additionally, the agency requested confirmation of the device’s sharps injury prevention feature. Inovio anticipates beginning shipments in approximately 60 days, with a full commercial rollout planned for the first quarter of 2027.
RRP is primarily caused by HPV types 6 and 11, which account for over 90% of cases. Patients often endure frequent surgeries to remove airway obstructions. Voceryq introduces a non-surgical alternative, delivering a 1 mL dose every three weeks over four treatments. Each administration requires at least 30 minutes of post-treatment monitoring for local reactions, and only providers trained on the Cellectra 5PSP device may administer it.
The FDA’s decision relied on a single-arm trial involving 32 adults. Among the 26 patients evaluated for effectiveness, 27% avoided surgery for a full year after treatment. All participants had undergone at least three surgeries in the prior 12 months. A follow-up study showed that 14 of 28 participants required no surgery in the second year. The agency granted accelerated approval based on reduced surgery frequency, an intermediate endpoint expected to predict clinical benefit. A confirmatory trial must be completed by August 2032 to assess long-term outcomes.
The Cellectra 5PSP device automates the injection and electroporation process in about 10 seconds. While it includes a sharps injury prevention feature, the FDA wants Inovio to validate this function. The agency’s updated human factors guidance, released in August 2026, stresses observing users during critical tasks to detect errors. Inovio must submit its final report by June 2027, either confirming no changes are needed or proposing modifications with supplemental testing.
Inovio previously encountered FDA scrutiny in 2016 when a Phase 3 trial for another DNA immunotherapy, VGX-3100, was paused. The hold resulted from insufficient shelf-life data for the Cellectra device’s disposable components. The trial resumed in June 2017 after the issue was resolved.
