Eisai CEO Not too Worried About Leqembi After CMS Keeps Anti-Amyloid Rule

Eisai’s CEO Ivan Cheung told Fierce Pharma he is not too worried about the long-term success of Leqembi in light of the US Centers for Medicare and Medicaid Services (CMS) declined to change its rule about reimbursement for drugs in its class. The rule states that drugs targeting amyloid, a key protein in Alzheimer’s disease, can only be covered for patients in clinical trials.

According to Fraiser Kansteiner, “Leqembi scored an accelerated approval in January, and Eisai filed for a traditional approval the very same day. Eisai believes its phase 3 trial, Clarity AD, along with its phase 2 study and long-term data on Leqembi “fully answers” CMS’ questions and qualifies as the sort of high-level evidence sought by the agency.”

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(Source: Fierce Pharma, March 21^st, 2023)