Precigen, Inc., a biopharmaceutical company specializing in precision medicine, has announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS as the first and only FDA-approved therapy for treating adults with recurrent respiratory papillomatosis (RRP). This historic milestone marks a significant breakthrough in addressing the root cause of RRP, a rare and debilitating disease caused by chronic HPV 6 or HPV 11 infection.
RRP affects approximately 27,000 adult patients in the US and can lead to severe voice disturbance, compromised airway, and recurrent post-obstructive pneumonias. Current management options primarily consist of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity and patient burden.
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against papilloma cells expressing HPV 6/11. The therapy has been shown to induce HPV 6/11-specific T cell responses in patients with RRP, resulting in a significant reduction of symptoms and potential elimination of surgeries.
According to the pivotal study led by lead investigators Clint T. Allen, MD, and Scott M. Norberg, DO, at the National Institutes of Health, 51% (18 out of 35) of study patients achieved Complete Response, requiring no surgeries in the 12 months after treatment with PAPZIMEOS. The therapy was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.
Helen Sabzevari, PhD, President and CEO of Precigen, stated, “Today marks a historic turning point. With the landmark FDA approval of PAPZIMEOS, all adult RRP patients are now eligible for access to the first and only approved therapy that targets the root cause of the disease.”
Precigen plans to promote PAPZIMEOS immediately and has established Papzimeos SUPPORT, a comprehensive patient support program offering personalized services, including insurance navigation, financial assistance, and ongoing access support. The company will host a conference call on August 18 at 8:00 AM ET to provide additional details regarding the approval.
This milestone represents a significant achievement in addressing RRP, a disease with high unmet patient need. PAPZIMEOS offers a new therapeutic paradigm for RRP, and Precigen is committed to helping patients access this groundbreaking therapy.
Source: https://www.prnewswire.com/news-releases/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-302530957.html