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After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion.
Biogen will find out in July if the FDA has granted its Alzheimer's drug Leqembi full approval.
Can Leqembi Succeed Where Aduhelm Flopped?
FILE - This Dec. 21, 2022, image provided by Eisai in January 2023 shows vials and packaging for their medication Leqembi.
Source: https://ktar.com/story/5432748/why-a-new-alzheimers-drug-is-having-a-slow-us-debut/
Image provided by Eisai in January 2023 shows vials and packaging for their medication Leqembi.
In January, the U.S. Food and Drug Administration approved Leqembi for people with mild cognitive decline after it was shown to reduce plaque by a statistically significant amount.
Source: https://www.dailyherald.com/entlife/20230903/updates-in-time-for-world-alzheimers-month
Public Citizen, an advocacy group, has urged the FDA to postpone its decision on whether to approve Leqembi while the companies finish the additional clinical trials needed for full approval.
That is why Eisai to price Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year, well below the quantified societal value of $37,600 in the U.S. This is an estimated annual cost of 10mg/kg IV biweekly for an average US patient weight of 75kg.
The drug, Lecanemab, will be sold under the name Leqembi and is a monoclonal antibody infusion administered every two weeks for patients with mild cognitive impairment.
The drug, Leqembi, is the first to convincingly show it can slow the decline in memory and thinking that defines Alzheimer’s by targeting its underlying biology.
The federal coverage program mainly for people ages 65 and older announced last month that it will cover Leqembi shortly after the Food and Drug Administration gave the treatment full approval.