WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), marking the first approved medical therapy for adults with recurrent respiratory papillomatosis (RRP), a rare and chronic condition caused by persistent human papillomavirus (HPV) infection.
RRP leads to the growth of benign tumors in the respiratory tract, most often the larynx, and is associated with serious complications such as voice changes, airway obstruction, and breathing difficulties. Until now, patients relied primarily on repeated surgical procedures to manage the disease.
Papzimeos, developed by Precigen, Inc., is a non-replicating adenoviral vector-based immunotherapy administered via subcutaneous injection. It targets HPV types 6 and 11, the primary drivers of RRP, by stimulating an immune response against infected cells.
Clinical data supporting approval came from a single-arm trial of adult patients who previously required at least three surgeries annually. Results showed that more than half of the participants (51.4%) achieved a complete response, defined as avoiding additional surgery for at least 12 months following treatment. Many patients maintained durable benefit for up to two years, with responses closely tied to HPV-specific immune activity.
The therapy demonstrated a favorable safety profile, with most side effects classified as mild to moderate and no treatment-related serious adverse events reported.
“Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy,” said Dr. Vinay Prasad, Director of the FDA’s Center for Biologics Evaluation and Research. He noted that the agency tailors trial requirements to reflect both disease rarity and medical need.
Granted both Breakthrough Therapy and Orphan Drug designation, Papzimeos was reviewed under the FDA’s Priority Review program, underscoring its significance as a long-awaited option for patients facing a disease with limited alternatives.
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