FDA Accelerated Approval of Voceryq: First Plasmid DNA Immunotherapy for Adult Recurrent Respiratory Papillomatosis

　　Recurrent respiratory papillomatosis(RRP)is a rare,chronic disease caused by persistent HPV-6 and HPV-11 infection.Benign papillomas grow on the laryngeal,vocal cord,and other respiratory mucosal surfaces.Although the lesions are not malignant,they often recur,causing hoarseness,airway narrowing,and in severe cases,breathing difficulty.Standard care relies on repeated surgery to remove visible lesions,but the underlying viral reservoir remains,so recurrence is common.Frequent procedures also raise the risk of permanent vocal cord damage.

　　On October 30,2026,the FDA granted accelerated approval to Voceryq,developed by Inovio Pharmaceuticals,for adults with RRP to reduce the frequency of papilloma-related surgery.It is the first approved plasmid DNA immunotherapy in the United States.

　　Voceryq contains two plasmid DNA constructs:one encodes HPV-6 and HPV-11 antigens,the other encodes IL-12 to enhance immune activation.It is delivered by intramuscular injection using the CELLECTRA 5PSP electroporation device,which helps plasmids enter cells and induce HPV-specific T-cell responses.Visible lesions should be removed surgically before therapy begins,followed by a 9-week dosing schedule.The drug does not directly excise existing papillomas.

　　The approval was based on the open-label RRP-001 study.In the efficacy analysis population of 26 patients—who had averaged about 4.5 surgeries in the prior year—27%required no papilloma surgery during 12 months of follow-up.Overall surgical frequency declined,but not all patients achieved surgery-free status.

　　Voceryq is indicated only for adults,not pediatric RRP.As an accelerated approval,continued confirmation depends on post-marketing confirmatory trials.It does not replace surgery,and some patients will still need surgical intervention.Common adverse reactions include injection-site pain and swelling,fatigue,headache,dizziness,and nausea,mostly mild to moderate.

　　Voceryq represents a shift from purely mechanical lesion removal toward immune control of the viral driver.It is not a cure,but it offers a mechanism-based option to lower surgical burden and extend surgery-free intervals.