The US Food and Drug Administration (FDA) has approved a new therapy, Papzimeos, for adults with recurrent respiratory papillomatosis (RRP), a rare disease that causes growth of benign tumors in the respiratory tract due to human papillomavirus (HPV) infection. The approval is significant as it marks the first treatment to win FDA regulatory approval for RRP.
The disease can be fatal, and a distinguishing aspect is its tendency for tumors to return even after surgical procedures. However, Papzimeos has shown promising results in early-to-mid-stage studies, with 51% of patients requiring no surgeries in the 12 months after treatment.
According to estimates, there are approximately 27,000 adult RRP patients in the US. The FDA approval is expected to bring relief to patients who have undergone numerous surgeries due to the condition. H.C. Wainwright analysts predict peak sales of $1.1 billion by 2033.
This approval highlights a shift in the FDA’s approach, with Vinay Prasad stating that randomized trials are not always necessary for medical product approvals. The treatment is designed to stimulate an immune response against HPV types 6 and 11, which cause RRP.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/precigen-shares-jump-after-us-fda-approves-first-therapy-rare-respiratory-2025-08-15