Precigen Receives Approval for PAPZIMEOS, First Therapy for Adults with Recurrent Respiratory Papillomatosis
Saturday, August 16, 2025
Precigen has received approval from the US Food and Drug Administration (FDA) for PAPZIMEOS™ (zopapogene imadenovec-drba), the first authorised treatment for adults with recurrent respiratory papillomatosis (RRP).
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen derived from human papillomavirus (HPV) types 6 and 11, which are the underlying cause of RRP. The therapy is administered through four subcutaneous injections over a 12-week period.
RRP is a rare and chronic disease of the respiratory tract caused by persistent HPV 6 or HPV 11 infection. The condition can result in severe voice problems, airway obstruction, recurrent infections, and in some cases progression to cancer. Current management has largely depended on repeated surgeries to remove growths, a process associated with high patient and healthcare burden as well as long-term risks.
This marks the first time a therapy addressing the root cause of the condition has been made available, ending reliance on repeated surgical procedures.
The FDA decision is based on results from a pivotal open-label study in adults with RRP. The study achieved its primary safety and efficacy goals. Findings showed that 51% of patients (18 out of 35) achieved a complete response, with no surgeries required in the 12 months following treatment. Of these, the majority maintained this response for over two years. PAPZIMEOS was well tolerated, with no severe treatment-related adverse events reported. The therapy also demonstrated the ability to trigger HPV 6/11-specific immune responses, particularly in patients who responded to treatment.
Precigen plans immediate commercial launch of PAPZIMEOS in the United States. A dedicated support programme has been introduced to help patients gain access, including services related to insurance, financial support, and ongoing treatment guidance.
The company estimates that around 27,000 adults in the United States are affected by RRP. The approval of PAPZIMEOS is expected to significantly reduce the need for repeated surgical procedures and provide long-term improvements in patient outcomes.
Source: precigen.com
