FDA HQ in White Oak, Maryland (Getty / Endpoints News)

Opin­ion: How the FDA bent its rules for Bio­gen’s Alzheimer’s drug and why that’s bad for the en­tire bio­phar­ma in­dus­try

The FDA’s stun­ning ac­cel­er­at­ed ap­proval for Bio­gen’s Alzheimer’s drug Aduhelm, with lim­it­ed clin­i­cal ev­i­dence sup­port­ing the de­ci­sion, will have reper­cus­sions across the en­tire bio­phar­ma in­dus­try.

From com­pa­nies now dig­ging in­to new post-hoc analy­ses of failed tri­als, to oth­ers that can re­turn to search­ing for amy­loid be­ta-tar­get­ed drugs in search of a sim­i­lar ac­cel­er­at­ed ap­proval — when the bar is low­ered for every­one, it’s the com­pa­nies that put in the hard work to tru­ly prove their drugs are safe and ef­fec­tive that will be hurt.

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