Haruo Naito, Eisai CEO (Shoko Takayasu/Bloomberg via Getty Images)

Break­ing: FDA clears sec­ond Alzheimer's drug in 'foun­da­tion­al spark' for field

US reg­u­la­tors ap­proved Ei­sai and Bio­gen’s Alzheimer’s drug lecanemab, a land­mark mo­ment for the dis­ease and a sec­ond chance for the com­pa­nies af­ter their drug Aduhelm was a com­mer­cial flop in the face of cost and ef­fi­ca­cy con­cerns.

The FDA cleared the mon­o­clon­al an­ti­body un­der its ac­cel­er­at­ed ap­proval path­way, for use in pa­tients with mild cog­ni­tive im­pair­ment from Alzheimer’s who have con­firmed pres­ence of amy­loid be­ta pathol­o­gy pri­or to treat­ment, es­sen­tial­ly the same pop­u­la­tion in clin­i­cal tri­als. Like Aduhelm, which the com­pa­nies brought to mar­ket in June 2021, it claims to slow the pro­gres­sion of the neu­rode­gen­er­a­tive dis­ease. Ei­sai will sell the drug as Leqem­bi.

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