Precigen’s PAPZIMEOS Wins Full FDA Approval for Recurrent Respiratory Papillomatosis
Precigen, Inc. announced that the FDA has granted full approval to PAPZIMEOS (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). The decision makes PAPZIMEOS the first and only FDA-approved therapy for RRP, a rare and debilitating disease caused by chronic HPV 6 or HPV 11 infection. Unlike previous accelerated approvals, the agency’s decision does not require a confirmatory trial, underscoring the strength of the pivotal data.
“For more than a century, patients with RRP have relied on repeated surgeries to manage this relent...
