Eisai heads to FDA with subcutaneous version of Alzheimer’s treatment developed with Biogen

Ei­sai and Bio­gen said Tues­day that they start­ed an ap­pli­ca­tion for an un­der-the-skin main­te­nance dos­ing ver­sion of their Alzheimer’s treat­ment Leqem­bi.

The sub­cu­ta­neous sub­mis­sion was ex­pect­ed ear­li­er this spring, but Ei­sai said April 1 that the FDA re­quest­ed more im­muno­genic­i­ty da­ta. At the time, an­a­lysts called the de­lay “a tech­ni­cal­i­ty but still dis­ap­point­ing.” The FDA has now grant­ed the med­ica­tion a fast track des­ig­na­tion.

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