JCA Pulse › Ongoing JCA
Ongoing JCALunsotogene parvec: EU joint clinical assessment
Treatment of biallelic OTOF variant-associated hearing loss in adults and children
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Company
- Regeneron
- Therapy area
- ENT & respiratory · Hearing loss
- Indication
- Treatment of biallelic OTOF variant-associated hearing loss in adults and children
- Product type
- ATMP, Orphan designation
- EMA validation
- 21 May 2026
- JCA assessor
- G-BA, Germany
- Co-assessor
- NoMA, Norway
- Regulatory status
- Under EMA review; accelerated timetable reverted to standard 09/2026. FDA accelerated approval Apr 2026.
- Pivotal evidence
- CHORD (phase 1/2, open-label, Single-arm)
Scope
The PICO forecast
JCA Pulse forecasts 1–2 PICOs for Lunsotogene parvec, with 2 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.
Evidence
Fit against the likely scope
Lunsotogene parvec rests on CHORD, 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 Lunsotogene parvec dossier and projects the indirect comparison each comparator will need.
Countries
National translator and outlook
Germany and Norway 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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