The FDA rais­es hopes for Alzheimer's drugs with a new set of draft rules. But are they go­ing too far?

Bioreg­num

The view from John Car­roll

For years now the gold stan­dard for R&D in Alzheimer’s has fo­cused on gen­er­at­ing con­vinc­ing ev­i­dence that any new ther­a­py be­ing stud­ied could slow the cog­ni­tive de­cline of pa­tients and help pre­serve their abil­i­ty to per­form the kind of dai­ly func­tions that can keep a pa­tient in­de­pen­dent for a longer pe­ri­od of time.

That’s a hur­dle no one has man­aged to clear for well over a decade. So now, with late-stage clin­i­cal fail­ures pil­ing up, the FDA has set off down a path to adapt those stan­dards as re­searchers are pushed in­ex­orably in­to ear­li­er and ear­li­er forms of the dis­ease, ahead of the brain dam­age in­flict­ed by Alzheimer’s.

This article is for premium subscribers only

Upgrade to a premium subscription plan for unlimited access, and join our community of key biopharma players.

UPGRADE