FDA Approves Papzimeos for Adults With Recurrent Respiratory Papillomatosis

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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.

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Source: HealthDay

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