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Home » Alnylam to Pull Expanded Indication for Onpattro After CRL
Alnylam to Pull Expanded Indication for Onpattro After CRL
Alnylam Pharmaceuticals today announced that the FDA has issued a complete response letter (CRL) on its supplemental New Drug Application (sNDA) for Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis and will no longer pursue the expanded indication.