DENVER, Colo., Aug 15, 2025 (247marketnews.com)- Precigen (NASDAQ:PGEN) stated that the U.S. Food and Drug Administration (FDA) granted full approval for PAPZIMEOS, the first and only approved therapy for the treatment of adults with recurrent respiratory papillomatosis (RRP).
The approval is not conditional and does not require a confirmatory trial, marking a definitive regulatory win for both Precigen and the RRP patient community. PAPZIMEOS is designed to address the root cause of RRP, chronic HPV 6 or 11 infection, by generating a targeted immune response using a non-replicating adenoviral vector-based immunotherapy.
” For more than a century, since RRP was first recognized as a distinct disease, patients have had to rely on repeated surgeries to manage this relentless condition,” commented Helen Sabzevari, PhD, President and CEO of Precigen. “With the landmark FDA approval of PAPZIMEOS and broad label, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease.”
RRP is a rare but debilitating condition, impacting an estimated 27,000 adults in the U.S. Patients suffer from benign tumors in the airway, leading to chronic surgeries, severe voice disturbances, and increased respiratory risk. Until now, no FDA-approved therapies existed.
PAPZIMEOS is delivered through four subcutaneous injections over a 12-week period.
Landmark Clinical Results
Approval is based on a pivotal open-label study conducted at the National Institutes of Health:
- 51% of patients (18 of 35) achieved a Complete Response—no surgeries required for at least 12 months post-treatment
- Responses were durable with 15 of 18 patients maintaining surgical remission at 24 months
- The therapy was well-tolerated, with no dose-limiting toxicities or treatment-related events above Grade 2
- PAPZIMEOS induced HPV 6/11-specific T cell responses, especially in patients who responded to treatment
“This long-awaited FDA approval represents a momentous milestone for the RRP community,” added Kim McClellan, President of the RRP Foundation. “For the first time, adult patients with RRP have access to an FDA-approved therapy that offers the potential to reduce—or even eliminate—endless repeated surgeries.”
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