FDA in­sid­er re­view of­fers a stel­lar en­dorse­ment for Bio­gen’s con­tro­ver­sial ad­u­canum­ab to treat Alzheimer’s — but sta­tis­ti­cal analy­sis mars the pic­ture

The FDA just pub­lished its re­view of Bio­gen’s ap­pli­ca­tion for the ap­proval of ad­u­canum­ab to treat Alzheimer’s, and reg­u­la­tors de­liv­ered a sol­id en­dorse­ment for us­ing the one pos­i­tive Phase III tri­al for an ap­proval, adding out­comes from a much small­er safe­ty study to pro­vide the ad­di­tion­al da­ta need­ed to meet the FDA’s stan­dards for an OK.

Their con­clu­sion: Bio­gen has pro­vid­ed “ex­cep­tion­al­ly per­sua­sive” ev­i­dence of the drug’s ef­fi­ca­cy. The re­view al­so dis­miss­es safe­ty con­cerns, say­ing they can be ad­dressed in the la­bel. And they waved aside a mul­ti­tude of past fail­ures for oth­er drugs that tar­get be­ta amy­loid, say­ing that this drug is dis­tinct­ly dif­fer­ent from the rest while past tri­als could al­so have been spiked by poor de­sign.

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