Hope Realized: FDA Approves Papzimeos for Adults with Recurrent Respiratory Papillomatosis (RRP)

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FORT WORTH, Texas--(BUSINESS WIRE)--Aug 15, 2025--

The Recurrent Respiratory Papillomatosis Foundation (RRPF) is excited to share the news that the U.S. Food and Drug Administration (FDA) has granted full approval to Precigen’s Papzimeos (zopapogene imadenovec-drba) under Priority Review for the treatment of adults with Recurrent Respiratory Papillomatosis (RRP). Papzimeos is the first and only FDA-approved treatment for RRP. ( See FDA’s announcement here)

A moment of profound healing for the RRP Community

This is truly a remarkable day – the culmination of decades of advocacy, resilience, and unwavering commitment from patients, families, researchers, and supporters. The approval of the first non-surgical treatment for adults with RRP marks not only a scientific milestone, but an inflection point for the entire RRP community. We extend our deepest gratitude to the many individuals and institutions who helped make this breakthrough possible – from the investigators, NIH collaborators, and clinicians who advanced the science, to the industry partners, whose investment and commitment to this community helped bring this treatment to approval.

The FDA’s announcement is also a deeply personal victory for every voice that has spoken up, every surgery endured, and every hope held steadfast. At RRPF, we are honored to walk alongside this community, championing awareness, supporting research, and amplifying the lived experiences of those affected by this rare disease. We celebrate the light this approval brings and recommit ourselves to the journey ahead, ensuring that patients of every age and living beyond the U.S. can one day access safe, effective and nonsurgical treatments.

“For decades, our community has persevered through an isolating journey of countless surgeries, silence, and uncertainty. Yet while we continued to breathe, we continued to hope. Today, our hope is realized. Today, with the approval of Papzimeos our hope is no longer a dream, it’s a reality,” said Kim McClellan, President of RRPF. “This is a moment of profound healing, not just for the body, but for the spirit of every adult living with RRP. We finally have an FDA-approved treatment that targets the root cause of RRP and with it, the chance for many members of our community to reclaim lives unencumbered by RRP.”

Quick facts about Papzimeos (zopapogene imadenovec-drba):

• The first and only FDA-approved treatment for RRP
• Approved for adults with RRP
• The only treatment to target the underlying cause of RRP
• Papzimeos is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against papilloma cells expressing HPV 6/11 Delivered via four subcutaneous injections over a 12-week interval
• Patients can access Papzimeos SUPPORT for personalized services including insurance navigation, financial assistance, and ongoing access support, by calling (866) 827-8180.
• For Precigen’s full release here: 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

For those interested in learning more about resources available to individuals affected by RRP, visit www.RRPF.org/patient-and-caregiver-toolkit

Renewed hope and continued commitment

The FDA full approval of Papzimeos is a monumental step forward for the RRP community, but it is not the final destination. RRPF remains deeply committed to advancing research for all patients – including pediatric patients, who continue to face burdens of this disease without an approved therapeutic option, and patients around the world. This milestone fuels our resolve and fortifies our determination to see a future where all people living with RRP have the same hope realized. With strengthened movement, we will continue to advocate, collaborate, and push for the science that brings healing at every age and to every corner of the world.

About RRPF

The Recurrent Respiratory Papillomatosis Foundation (RRPF) was born from a parent’s urgent need to understand and confront a rare, chronic, and potentially life-threatening disease affecting their child. Since 1991, RRPF has been a lifeline for patients and families navigating the isolating journey of RRP – offering connection, advocacy, and hope.

What began as a grassroots effort has grown into a mission-driven organization united by the voices of parents, patients, and researchers. RRPF provides vital resources including access to the latest research, updates on clinical trials and medical meetings, and a supportive community for those affected by RRP. The foundation has played a pivotal role in advancing scientific understanding of RRP – contributing to research as authors, funders, and collaborators across multiple studies and initiatives.

RRPF honors the legacy of those like Jennifer Woo, a former president of RRPF whose life and career were dedicated to curing RRP, and continues to drive forward research, awareness, and support for all those impacted. While we breathe, we hope. Learn more here: www.rrpf.org.

View source version on businesswire.com:https://www.businesswire.com/news/home/20250815841136/en/

CONTACT: Media:

Kim McClellan, President RRPF

(331) 826-9050

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA TEXAS

INDUSTRY KEYWORD: SCIENCE RESEARCH GENERAL HEALTH HEALTH FDA HOSPITALS PHILANTHROPY FOUNDATION

SOURCE: Recurrent Respiratory Papillomatosis Foundation

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PUB: 08/15/2025 10:45 AM/DISC: 08/15/2025 10:46 AM

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