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FDA Approves First Therapy for Recurrent Respiratory Papillomatosis

8/15/2025

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Summary

Story summary

The FDA has approved Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis, the first therapy targeting the disease's root cause.
In a pivotal trial, 51% of patients achieved a complete response without surgery at one year, with 15 maintaining this response at two years.
The treatment is well-tolerated, with no severe adverse events reported.
This approval provides new options for patients previously dependent on repeated surgeries for RRP management.

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Story summary

The FDA has approved Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis, the first therapy targeting the disease's root cause.
In a pivotal trial, 51% of patients achieved a complete response without surgery at one year, with 15 maintaining this response at two years.
The treatment is well-tolerated, with no severe adverse events reported.
This approval provides new options for patients previously dependent on repeated surgeries for RRP management.