Regeneron Pharmaceuticals said Otarmeni has been accepted by the European Medicines Agency for review under Accelerated Assessment for marketing authorization in biallelic OTOF variant-associated hearing loss. The update is a regulatory step forward for the treatment but does not constitute approval. Market impact should be limited unless the review leads to a faster-than-expected approval.
Regeneron Pharmaceuticals said Otarmeni has been accepted by the European Medicines Agency for review under Accelerated Assessment for marketing authorization in biallelic OTOF variant-associated hearing loss. The update is a regulatory step forward for the treatment but does not constitute approval. Market impact should be limited unless the review leads to a faster-than-expected approval.
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