'Bi­ased and mis­lead­ing': No holds barred in FDA's sta­tis­ti­cal re­view of Bio­gen's Aduhelm

New FDA re­view doc­u­ments from the Aduhelm de­ci­sion re­leased Mon­day make clear why the agency’s own sta­tis­ti­cians dis­sent­ed on the con­tro­ver­sial ac­cel­er­at­ed ap­proval.

At the cen­ter of the ac­cel­er­at­ed ap­proval, ac­cord­ing to the near­ly 400-page clin­i­cal re­view, is two large, in­ter­na­tion­al piv­otal tri­als (Stud­ies 301 and 302) that were near­ing com­ple­tion but were ter­mi­nat­ed pri­or to their planned con­clu­sion. Mod­el­ing and sim­u­la­tion al­lowed the FDA and Bio­gen to com­plete those two tri­als, which es­tab­lished that their re­sults were in­ter­pretable and suit­able for ad­di­tion­al con­sid­er­a­tion. Where­as the pos­i­tive Study 302 “pro­vides the pri­ma­ry ev­i­dence of ef­fec­tive­ness” for the ap­proval, Study 301 failed.

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