FDA Approves Papzimeos for Adults With Recurrent Respiratory Papillomatosis

Follow Drugslib on

By Lori Solomon HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 21, 2025.

via HealthDay

THURSDAY, Aug. 21, 2025 -- The U.S. Food and Drug Administration has approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).

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 a 12-week period.

The approval is based on a trial in which half 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.

"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 in a 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."

Approval of Papzimeos was granted to Precigen.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-08-22 06:00

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords