FDA grants accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis

The FDA approved Voceryq, a plasmid DNA-based immunotherapy, for adults with recurrent respiratory papillomatosis (RRP), a chronic HPV 6- or 11-associated disease that causes airway papillomas and often requires repeated surgery. The therapy is administered by intramuscular injection with electroporation. The FDA’s decision used the accelerated approval pathway, based on reduced frequency of surgical procedures as an intermediate endpoint reasonably likely to predict clinical benefit.

Evidence came from an open-label, multicenter clinical trial involving 32 adults who had undergone at least two surgeries in the year before treatment, including a scheduled procedure at trial entry. Among the 26 patients with at least three baseline surgeries, seven (27%) required no surgical intervention during the first year after treatment. Commonly reported adverse reactions included injection-site reactions, headache, fatigue, hypertension, nausea and dizziness.

The FDA requires the manufacturer, Inovio Pharmaceuticals, to conduct post-approval trials to verify and describe clinical benefit. The reported result is limited to a small, open-label study and a first-year outcome; the source does not provide a comparator or further efficacy estimates. The agency also notes potential adverse effects associated with electroporation, including brief muscle contractions, bleeding at the administration site and vasovagal reactions.