Ackea's approval came with an asterisk
A two-page black box label was slapped onto Ackea’s freshly approved antisense drug, inotersen, which treats nerve pain associated with a rare and fatal disorder called hereditary transthyretin amyloidosis. The FDA strongly cautioned against the drug’s likelihood to cause kidney inflammation and thrombocytopenia, or a dangerously low platelet count.
By contrast, Alnylam won FDA approval for its own hATTR drug — patisiran — and no serious warnings were doled out.
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