lunes, 8 de octubre de 2018

FDA approves Akcea's rare disease drug with a black box warning - STAT

FDA approves Akcea's rare disease drug with a black box warning - STAT

The Readout

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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