The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), a plasmid DNA-based immunotherapy, for the treatment of adults with recurrent respiratory papillomatosis (RRP). This approval marks the first time a plasmid DNA-based immunotherapy has been approved in the United States for this indication.
Voceryq is a recombinant plasmid DNA-based immunotherapy designed to stimulate the body's immune system to attack cells infected by the specific types of human papillomavirus (HPV) that cause RRP, specifically HPV types 6 and 11. The therapy is administered via intramuscular injection using the CELLECTRA 5PSP Device, which facilitates electroporation to enable the delivery of the DNA into the body's cells.
The FDA based this approval on clinical trial data showing that Voceryq helps reduce the frequency of surgical procedures required to remove growths in adult patients with RRP. The agency evaluated the safety and effectiveness of Voceryq in an open-label multicenter clinical trial involving 32 adults diagnosed with RRP. Eligible patients had undergone two or more surgeries to remove laryngotracheal papillomas in the 12 months prior to treatment.
According to the trial results, 27% of the 26 patients who had at least three baseline surgeries did not require any surgical intervention during the first year after treatment. The most commonly reported adverse reactions to Voceryq included injection site reactions, headache, fatigue, hypertension, nausea, and dizziness. Adverse effects associated with the electroporation technique may include brief muscle contractions, temporary bleeding at the administration site, anxiety, vasovagal reactions, transient changes in creatine phosphokinase, erythema, and pain at the injection site.
The FDA granted Voceryq Breakthrough and Orphan Drug designations. The approval was granted to Inovio Pharmaceuticals, Inc.
