FDA Approves First Treatment for Recurrent Respiratory Papillomatosis

RRP is a rare chronic disease that leads to growth of benign tumors in the larynx, causing voice changes and breathing difficulties.
Aug. 15, 2025

The FDA has approved the first treatment for adult patients with recurrent respiratory papillomatosis (RRP).

The medication, called Papzimeos, is a “first-of-its-kind non-replicating adenoviral vector-based immunotherapy.” During the trial, the medication was administered via four subcutaneous injections over 12 weeks following surgical debulking (reduction) procedures. 51.4% of patients in the trial “achieved a complete response—defined as no need for surgical intervention in the 12 months following treatment. Follow-up data showed that durable responses were maintained in most patients through two years, with a strong correlation between clinical benefit and the induction of HPV 6/11-specific T cells.”

RRP is a “rare, chronic disease caused by persistent human papillomavirus (HPV) 6 or 11 infection, leading to the growth of benign tumors in the respiratory tract, most commonly the larynx. The disease is associated with significant morbidity, including voice changes, breathing difficulties, and airway obstruction. There are currently no approved medical therapies that eliminate the need for repeated surgical procedures.” An estimated 1,000 new cases are diagnosed annually in the U.S.

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Matt MacKenzie

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Matt is Associate Editor for Healthcare Purchasing News.

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