Precigen Gains Advantage as PAPZIMEOS Granted Orphan Drug Exclusivity by FDA; Long-Term Data From Clinical Study Encouraging
Precigen secured FDA orphan drug exclusivity for PAPZIMEOS, its treatment for recurrent respiratory papillomatosis (RRP), granting seven years of market protection through August 2032. This regulatory win coincides with the release of encouraging long-term durability data from the pivotal study presented at ASCO, showing 83% of complete responders maintained their response for at least 36 months without additional treatment.
Key figures
- Drug Name
- PAPZIMEOS (zopapogene imadenovec-drba)
- Exclusivity end date
- August 2032
- Exclusivity period years
- 7
- Patients surgery free 4 years
- 5
- Complete response rate long term
- 83%
- Total complete responders in study
- 18
AI analysis
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