FDA approves Papzimeos for adults with Recurrent Respiratory Papillomatosis; all you need to know about the ‘life-threatening’ RRP disease

The United States Food and Drug Administration (FDA) has given its approval to Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The approval was granted to Precigen based on a trial in which 51 percent of study patients (18 of 35) achieved a complete response, requiring no surgeries in the 12 months after treatment with Papzimeos.

Of these 18 patients, 15 continued to show a complete response at 24 months. No dose-limiting toxicities were reported with Papzimeos, and no treatment-related adverse events greater than grade 2 were seen, Precigen said in a statement. "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," Helen Sabzevari, Ph.D., president and CEO of Precigen, said, according to the company statement.

"Today marks a historic turning point. 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," it further stated.


Papzimeos is a nonreplicating, adenoviral vector-based immunotherapy that expresses a fusion antigen made up of selected regions of human papillomavirus (HPV) types 6 and 11 proteins, the root cause of RRP. Papzimeos is administered via four subcutaneous injections over 12 weeks.

What is RRP

RRP 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, Precigen said in its statement.

RRP can lead to severe voice disturbance, compromised airway, and recurrent post-obstructive pneumonias. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal, the statement further read. The company said that the management of RRP has primarily consisted of repeated surgeries, which do not address the underlying cause of the disease and can be associated with significant morbidity as well as significant patient and health system burden.

How can RRP impact the lives of patients

RRP can impact patients' work and social lives, financial stability, and mental health, the company revealed in its statement. Patients with RRP can experience substantial impacts to daily living with decreased quality of life and high health care utilization. Based on an internal analysis of claims data and electronic health records, there are approximately 27,000 adult RRP patients in the US, the statement added.