Ju­ly de­ci­sion date set for full ap­proval of Ei­sai's Alzheimer's drug, with an ad­comm com­ing too

The last time the FDA held an ad­vi­so­ry com­mit­tee meet­ing for an Alzheimer’s drug, Bio­gen’s Aduhelm (ad­u­canum­ab) was unan­i­mous­ly re­ject­ed by the com­mit­tee, and even­tu­al­ly led to mul­ti­ple com­mit­tee mem­ber res­ig­na­tions af­ter Aduhelm won ac­cel­er­at­ed ap­proval.

This time, with Ei­sai and Bio­gen’s Leqem­bi (lecanemab), the agency will look to clear that ten­u­ous air, and show that amy­loid-low­er­ing drugs can pro­vide clin­i­cal ben­e­fits. When that ad­comm meet­ing will be held re­mains un­known, but Bio­gen an­nounced late Sun­day that a pri­or­i­ty re­view de­ci­sion on the full ap­proval of its Alzheimer’s drug — like­ly clear­ing the way for broad CMS and in­sur­er cov­er­age — will be on or be­fore Ju­ly 6.

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