FDA asks Bio­gen and Ei­sai to pro­vide more da­ta on sub­cu­ta­neous Leqem­bi

Ei­sai and Bio­gen’s plan to bring a sub­cu­ta­neous ver­sion of its Alzheimer’s drug Leqem­bi to mar­ket is fac­ing a de­lay.

The FDA re­quest­ed more in­for­ma­tion on the sub­cu­ta­neous form’s im­muno­genic­i­ty, Ei­sai said in a press re­lease Mon­day morn­ing. The com­pa­ny had planned to start a rolling re­view last month in or­der to com­pen­sate for the lack of da­ta, but the process would have re­quired a sep­a­rate fast track des­ig­na­tion for the sub­cu­ta­neous drug.

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