Alnylam's potential fourth RNAi approval delayed three months, but impact likely to be 'modest'

Alnylam, looking to best its own ATTR drug Onpattro, will have to wait up to three months longer than originally slated for an FDA decision on its investigational med vutrisiran.

The agency plans to decide the fate of Alnylam’s fourth RNAi therapeutic on July 14. The FDA doesn’t want any more clinical data, but newly added information related to the “new secondary packaging and labeling facility” needs to be reviewed, Alnylam said Monday morning.