JCA Pulse › Ongoing JCA
Ongoing JCAZopapogene imadenovec: EU joint clinical assessment
Treatment of respiratory papillomatosis in adults
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Company
- Precigen
- Therapy area
- ENT & respiratory · Respiratory papillomatosis
- Indication
- Treatment of respiratory papillomatosis in adults
- Product type
- ATMP, Orphan designation
- EMA validation
- 27 Nov 2025
- JCA assessor
- Danish Medicines Council, Denmark
- Co-assessor
- AIHTA, Austria
- Regulatory status
- Under EMA review; no CHMP opinion found as of 5 Nov 2026. FDA-approved for adults with RRP.
- Pivotal evidence
- Phase 1/2 pivotal (NCT04724980), single centre (Single-arm)
Scope
The PICO forecast
JCA Pulse forecasts 1 PICO for Zopapogene imadenovec, with 1 candidate comparator. See the populations, comparators and likely outcomes the assessment is set to cover.
Evidence
Fit against the likely scope
Zopapogene imadenovec rests on Phase 1/2 pivotal, evidence without a randomised comparator. Pro shows which likely PICOs it can answer, and where the gaps sit.
Comparisons
Trials and indirect comparisons
Pro maps every trial likely in the Zopapogene imadenovec dossier and projects the indirect comparison each comparator will need.
Countries
National translator and outlook
Denmark and Austria lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets.
Sources
Last checked 5 November 2026. Compiled from public sources; check them for the latest position. Forecasts are Evidaxia’s independent view, not official assessments.
From Evidaxia
- EU JCA dossiers and PICO scopingSupport from PICO scoping to the dossier
- JCA PICO scoping: process and preparationHow assessors set the scope
- EU JCA timelineEvery upcoming milestone
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