FDA Approves Papzimeos, a New Treatment for Adults with Recurrent Respiratory Papillomatosis

The U.S. Food and Drug Administration (FDA) has granted approval to Papzimeos (zopapogene imadenovec-drba), marking a significant advancement in the treatment of adults suffering from recurrent respiratory papillomatosis (RRP). RRP is a chronic condition characterized by the growth of benign tumors in the respiratory tract, often requiring repeated surgeries to manage the symptoms and prevent airway obstruction.

Papzimeos is a novel immunotherapy that utilizes an adenoviral vector to deliver a fusion antigen derived from HPV types 6 and 11 proteins, the primary viral strains responsible for RRP. Unlike traditional methods that rely heavily on surgical removal of papillomas, this therapy aims to target the underlying cause of the disease. Administered through four subcutaneous injections spaced over a 12-week period, Papzimeos offers a potential long-lasting solution for affected individuals.

The FDA's decision was based on clinical trial results involving 35 patients, where half of them (18 patients) achieved complete eradication of papillomas, eliminating the need for further surgeries during the subsequent 12 months. Impressively, 15 of these patients maintained their response at 24 months post-treatment. Importantly, the therapy demonstrated a favorable safety profile, with no dose-limiting toxicities or adverse events exceeding grade 2.

Helen Sabzevari, Ph.D., President and CEO of Precigen, the company behind Papzimeos, expressed optimism about the approval. She highlighted that this milestone could transform the management of RRP, a condition that has historically relied on frequent surgical interventions. The approval allows broad access to the first therapy specifically targeting the root cause of RRP in adults.

For more detailed information, visit the related press release at Precigen's official site.

Source: https://medicalxpress.com/news/2025-08-fda-papzimeos-adults-recurrent-respiratory.html