In a complete response letter, the FDA said the clinical meaningfulness of patisiran's effects in cardiomyopathy of ATTR amyloidosis are not established, despite good reviews from an advisory panel.
Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit.ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran's treatment effects for the cardiomyopathy of ATTR amyloidosis have"not been established," and therefore, the supplemental new drug application for patisiran"could not be approved in its present form."
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