On August 14, 2025, the FDA approved Papzimeos (zopapogene imadenovec-drba), the first immunotherapy for the treatment of adults with recurrent respiratory papillomatosis (RRP).

This is a rare, chronic disease caused by persistent infection with human papillomavirus (HPV) types 6 or 11, which produces benign tumors in the respiratory tract, especially the larynx, causing voice changes, breathing difficulties, and a risk of airway obstruction.

Until now, there were no approved medical therapies to reduce the need for repeated surgical interventions, which were the main treatment.

WHOM DOES IT IMPACT?

The direct impact is on adult patients, specialist physicians, hospitals, manufacturers, and importers.

CONCLUSION:

The approval of Papzimeos opens a new era in the treatment of RRP, offering an effective alternative with a long-lasting response and a good safety profile, which could significantly reduce dependence on surgical interventions and improve patients' quality of life.