FDA grants accelerated approval to Inovio’s Voceryq

The US Food and Drug Administration (FDA) has granted accelerated approval to Inovio Pharmaceuticals’ Voceryq, a pioneering plasmid DNA-based immunotherapy. The treatment is designed for adult patients with recurrent respiratory papillomatosis (RRP), a rare disease caused by human papillomavirus (HPV) types 6 and 11 that leads to growths in the airway.

In clinical trials, Voceryq demonstrated the potential to reduce the frequency of surgical interventions. Among 26 efficacy-evaluable patients who previously required multiple surgeries, 27 percent achieved a complete response, requiring no additional surgery for 12 months following treatment. The therapy is administered via the Cellectra 5PSP device, which uses electrical pulses to facilitate DNA delivery into cells.

As part of the accelerated approval, the FDA has requested that Inovio reanalyze human factors testing for the Cellectra 5PSP device and verify its sharps injury prevention features. Inovio expects to begin orders and shipments within approximately 60 days, with a full commercial launch planned for the first quarter of 2027.