WASHINGTON, D.C. — In case you missed it, the U.S. Food and Drug Administration granted accelerated approval last week to Inovio Pharmaceuticals’ Voceryq, the first plasmid DNA-based immunotherapy authorized in the United States, offering adults with recurrent respiratory papillomatosis a treatment that could reduce the need for repeated airway surgeries.
The approval introduces a nonsurgical treatment option for recurrent respiratory papillomatosis, or RRP, a rare, chronic disease caused by human papillomavirus types 6 and 11. The condition produces wart-like growths in the respiratory tract, particularly around the vocal cords, that frequently require surgical removal.
Voceryq, known chemically as doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, received accelerated approval based on clinical evidence showing a reduction in the frequency of surgeries required to remove airway growths.
The FDA relied on that reduction as an intermediate clinical endpoint reasonably likely to predict clinical benefit. Under the accelerated approval pathway, Inovio must conduct post-approval trials to verify and describe the treatment’s clinical benefits.
The agency evaluated Voceryq in an open-label, multicenter clinical trial involving 32 adults with RRP. Participants were required to have undergone at least two surgeries to remove laryngotracheal papillomas during the preceding 12 months, including a scheduled procedure at enrollment.
Among 26 patients who had undergone at least three surgeries before treatment, seven, or 27%, required no surgical intervention during the first year following therapy.
The findings indicate that treatment may reduce the surgical burden for some patients, although the trial was relatively small and did not include a control group.
RRP develops when HPV infection causes papillomas to form along the airways. Symptoms can include hoarseness, chronic coughing and changes in voice quality, while more severe disease can obstruct breathing.
Surgery removes the growths but does not eliminate the underlying viral infection. As a result, patients may undergo repeated procedures over many years, and some cases carry a risk of malignant transformation.
“Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it,” said Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research.
Voceryq is designed to stimulate an immune response against cells infected with HPV types 6 and 11. It uses two plasmids containing genetic instructions for HPV-related proteins and interleukin-12, an immune response-enhancing molecule.
The treatment is administered through intramuscular injection using the CELLECTRA 5PSP device, which applies brief electrical pulses to temporarily increase cell membrane permeability and facilitate delivery of the DNA-based therapy.
The delivery method, known as electroporation, can cause temporary muscle contractions, pain, bleeding or redness at the injection site, dizziness and other short-term reactions.
The most commonly reported adverse reactions to Voceryq included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness.
The FDA previously granted Voceryq Breakthrough Therapy and Orphan Drug designations, regulatory classifications intended to support development of treatments for serious conditions and rare diseases.
The accelerated approval permits Inovio to market Voceryq for adults with RRP while the company completes the additional clinical studies required to confirm its benefit.
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