FDA adds ‘breakthrough’ status for Alnylam as patisiran starts its victory lap at the agency
With Alnylam’s rolling application for its landmark RNA therapy patisiran just weeks from completion, the FDA has come through with a breakthrough drug designation that may well trim its time to market.
The Cambridge/Boston biotech reported this morning that the agency had issued its BTD — providing VIP status at the agency — based on some stellar Phase III data in hereditary transthyretin-mediated ATTR amyloidosis — or hATTR amyloidosis.
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