FDA puts added em­pha­sis on amy­loid in up­date on Alzheimer's R&D guid­ance

The FDA on Mon­day re­leased new­ly-re­vised guid­ance on ear­ly Alzheimer’s dis­ease drug de­vel­op­ment, in­clud­ing a sec­tion that boosts the case for us­ing amy­loid re­duc­tion as a sur­ro­gate end­point that’s pre­dic­tive of clin­i­cal ben­e­fit.

This re­vi­sion, a sec­ond since the guid­ance was first is­sued in 2013, de­scribes FDA’s cur­rent think­ing re­gard­ing the use of bio­mark­ers for the se­lec­tion of par­tic­i­pants with ear­ly stages of Alzheimer’s dis­ease for en­roll­ment in clin­i­cal tri­als.

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