biotech / news / / The Manila Times
Groundbreaking AAV-based gene therapy offers potential treatment for patients with OTOF gene-associated severe-to-profound and profound hearing loss.
The FDA approved Otarmeni, the first-ever dual AAV vector-based gene therapy for OTOF-related hearing loss.
KEY POINTS
- Otarmeni approval was granted just 61 days after BLA filing, tying the fastest in FDA history.
- Eighty percent of evaluable pediatric patients showed improved hearing after Otarmeni treatment in clinical trials.
- Otarmeni is a one-time, surgically administered biologic-device combination delivering OTOF gene via dual AAV1 vectors.
- Otarmeni is the first gene therapy approved under the Commissioner's National Priority Voucher pilot program.
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