Alnylam's vutrisiran PDUFA delayed 3 months to July 14, 2022 on packaging facility issue

ALNYLAM PHARMACEUTICALS, INC.

FDA extended review to July 14, 2022 due to amendment addressing inspection classification at third-party packaging/labeling facility.
New secondary packaging and labeling facility identified and submitted to FDA; no inspection observations directly related to vutrisiran.
No additional clinical data requested by FDA; vutrisiran under concurrent review by EMA, ANVISA, and PMDA.
Alnylam aims to minimize impact on other regulatory reviews through timely resolution or alternative facility.

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