Alnylam Pharmaceuticals Inc. got a reminder of the necessity of following US Food and Drug Administration guidance on 9 October when it received a complete response letter for its supplemental new drug application seeking to add an ATTR cardiomyopathy indication to Onpattro’s label.
Alnylam Drops Label-Expansion Effort For Onpattro After FDA Complete Response
Giving up on adding a cardiomyopathy indication to Onpattro’s label, Alnylam now will focus on adding that disease to Amvuttra’s label. Onpattro got a thumbs-up from an FDA advisory panel in September.
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