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Precigen Announces Full FDA Approval of PAPZIMEOS (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
PAPZIMEOS approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP
About this update from Precigen, Inc.
[{"type":"text","content":"PAPZIMEOS approval marks a historic milestone for the RRP patient community as the first and only FDA-approved therapy for the treatment of adults with RRP PAPZIMEOS received full approval from the FDA for the treatment of adults with RRP; a confirmatory clinical trial is no longer required RRP is a rare, debilitating, and potentially life-threatening disease caused by chronic HPV 6 or HPV 11 infection, which results in recurrent benign tumors in the respiratory tract; RRP affects an estimated 27,000 adult patients in the USPAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against papilloma cells expressing HPV 6/11—the first and only approved therapy to treat the root cause of RRP Precigen will host a conference call on Monday, August 18 at 8:00 AM ETGERMANTOWN, Md, Aug. 15, 2025 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP. Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted PAPZIMEOS full approval, which does not require a confirmatory clinical trial. PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins—the root cause of RRP. PAPZIMEOS is delivered via four subcutaneous injections over a 12-week interval.\n\n \n \n \n \n \n \n\n \nRRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, a compromised airway, and recurrent post-obstructive pneumonias. Management of RRP has primarily consisted of repeated surgeries, which do not address the root cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden.\n\"...