Inovio's Voceryq Receives FDA Approval for RRP Treatment
Inovio Pharma's plasmid DNA immunotherapy, Voceryq, has been granted accelerated FDA approval for adults with recurrent respiratory papillomatosis (RRP). This novel treatment offers a non-surgical option for a condition caused by HPV, which leads to airway lesions. Voceryq aims to reduce the need for repeated surgeries and improve patients' quality of life.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Inovio Pharmaceuticals for its plasmid DNA-based immunotherapy, Voceryq. This treatment is the first of its kind for adults with recurrent respiratory papillomatosis (RRP), a rare and often debilitating condition caused by the human papillomavirus (HPV). RRP causes wart-like lesions to develop in the airways, particularly the larynx, which can result in breathing difficulties and changes to the voice. Generally caused by HPV strains 6 and 11, the condition typically requires patients to undergo multiple surgeries to remove these growths, which can occasionally become cancerous over time.
Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid) is designed to trigger an immune response against these specific HPV strains. Clinical trials indicate the therapy can help reduce the frequency of surgeries for those living with the condition, providing an alternative to the exhausting cycle of repeated operations. Karim Mikhail, director of the FDA's Center for Biologics Evaluation and Research, emphasized the importance of the breakthrough, stating that the new immunotherapy harnesses the body's own immune system to combat the underlying cause of RRP. The approval offers a non-surgical option for patients looking to lessen the daily burden of the disease.
Inovio expects to begin shipping Voceryq within 60 days, with a full commercial launch planned for the first quarter of 2027. Although the company has not yet disclosed a list price, it may share further details in a call later today. This follows the August 2025 approval of Precigen's Papzimeos, another non-surgical option that highlights the growing focus on RRP treatments. According to the FDA, about 1,000 new cases of RRP are diagnosed in the United States every year, and roughly 27,000 adults live with the condition at any given time. The arrival of Voceryq marks a significant advancement in RRP management, providing a new treatment path and the potential for improved quality of life as research in the field continues.
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