FDA faulted Amvuttra mortality claims before closing the matter
The FDA sent Alnylam an untitled letter in April over claims on the consumer website for its ATTR-CM drug Amvuttra, according to the agency's letters index.
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The FDA sent Alnylam an untitled letter in April over claims on the consumer website for its ATTR-CM drug Amvuttra, according to the agency's letters index.
The April 23 letter challenged statements that Amvuttra was proven to help people with ATTR-CM live longer, along with a graphic showing a 36% lower risk of death over three and a half years, Covington summarized. The figure drew on an open-label extension of the HELIOS-B trial. By then all placebo patients had switched to Amvuttra, leaving no concurrent comparison group.
The agency said the open-label design introduced bias and confounding, and that a disclaimer on the site did not fix the problem, Fierce Pharma reported.