The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Voceryq, a first-of-its-kind plasmid DNA-based immunotherapy for adults living with recurrent respiratory papillomatosis (RRP), a rare and chronic disease caused by human papillomavirus (HPV).
The approval marks a significant advancement in the treatment of RRP, which causes wart-like growths in the respiratory tract, particularly around the voice box and vocal cords. Patients frequently experience hoarseness, persistent coughing, voice changes and, in severe cases, breathing difficulties.
Unlike conventional surgical procedures that remove visible growths without eliminating the underlying virus, Voceryq is designed to activate the body's immune system to recognize and attack cells infected with HPV types 6 and 11. The therapy uses two recombinant plasmids: one carrying genetic instructions for specific HPV proteins and another containing interleukin-12 (IL-12), an immune-response-enhancing molecule.
Voceryq is administered through intramuscular injection using the CELLECTRA 5PSP device, which employs brief electrical pulses to facilitate the delivery of the therapy into cells.
The FDA's accelerated approval was supported by clinical trial data involving 32 adults diagnosed with RRP. Among the 26 patients who had undergone at least three surgeries before treatment, seven (27%) did not require any surgical intervention during the first year following treatment. The findings suggest that Voceryq may help reduce the frequency of repeated surgical procedures, potentially improving patients' quality of life.
The most commonly reported adverse reactions included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. Additional effects associated with the electroporation procedure may include temporary muscle contractions, bleeding, lightheadedness and injection-site pain.
The FDA granted Voceryq Breakthrough Therapy and Orphan Drug designations before approving it through the accelerated approval pathway. The manufacturer, Inovio Pharmaceuticals, Inc., is required to conduct post-approval clinical trials to confirm and further describe the therapy's clinical benefits.
The approval represents an important milestone in the development of DNA-based immunotherapies and provides a new treatment option for adults affected by recurrent respiratory papillomatosis.
By targeting HPV-infected cells rather than simply removing visible growths, Voceryq could help reduce the long-term burden of repeated surgeries for patients living with this challenging condition.
