Posted by Michael Wonder on 09 Oct 2023
Alnylam announces receipt of complete response letter from US FDA for supplemental new drug application for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis
9 October 2023 - FDA cites insufficient evidence of clinical meaningfulness.
Alnylam Pharmaceuticals today announced that the US FDA has issued a complete response letter in response to the Company’s supplemental new drug application for patisiran for the treatment of the cardiomyopathy of transthyretin-mediated amyloidosis.
