The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba) as the first therapy for adults with recurrent respiratory papillomatosis (RRP), a rare condition driven by human papillomavirus (HPV) types 6 and 11.
Papzimeos is a nonreplicating, adenoviral vector–based immunotherapy that delivers a fusion antigen targeting HPV proteins responsible for the disease. Treatment involves four subcutaneous injections over a 12-week period.
Approval was supported by clinical trial data showing that 51% of patients (18 of 35) achieved a complete response, eliminating the need for surgical intervention during the 12 months following treatment. Among those responders, 15 maintained remission for 24 months. Importantly, no dose-limiting toxicities were reported, and adverse events were limited to grade 2 or lower.
“For more than a century, patients with RRP have faced repeated surgeries to control this unrelenting condition,” said Helen Sabzevari, Ph.D., president and CEO of Precigen, in a statement. “This approval marks a historic turning point. For the first time, adults living with RRP have access to a therapy that targets the root cause of the disease.”
With this decision, Papzimeos becomes the first and only FDA-approved treatment for adult patients with RRP.
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