Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #21.19

Alzheimer’s disease treatments (follow up)

In a presentation to analysts, Ivan Cheung, Eisai neurology chief was confident that BAN 2401 or lecanemab would receive a fast approval by the US FDA in following the path of aducanumab or Aduhelm. “Under the breakthrough therapy designation from the FDA we (Eisai and Biogen its partner) have initiated communications with the FDA to seek the most optimal and expedited pathway forward for lecanemab. We explore all options with the FDA, we will listen to their advice, including the accelerated approval pathway” Cheung said.

BAN 2401 has strong plaque reduction effect similar to Eli Lilly’s donanemab, less side effects than Aduhelm and does not require titration although it will be dosed twice a month rather than once monthly for Aduhelm.

Now that the door at the FDA has been opened for Alzheimer’s drugs that demonstrate a reduction in amyloid, analysts expect Eli Lilly’s donanemab, Eisai and Biogen’s lecanemab as well as Roche’s gantenerumab to be approved in 2022.

Paris August 5, 2021

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