The FDA adds a failed Alzheimer's drug to the 'breakthrough' club now looking for a near-term OK
Almost 10 years to the day since Roche first whipped up enthusiasm for gantenerumab as a potential blockbuster therapy for Alzheimer’s — and more than 5 years after its pivotal failure forced a temporary burial ahead of a decision to resurrect it — researchers have been awarded the FDA’s breakthrough therapy designation.
The BTD designation will further encourage Roche execs to see if they can finally get this drug across the agency’s finish line. The FDA gave out the open-door pass to Roche in the wake of its ultra-controversial decision to provide an accelerated approval for Biogen’s Aduhelm based on its ability to clear toxic amyloid beta in the brain — despite the lack of clear evidence to prove that that can slow the loss of cognitive abilities or improve the ability to complete simple tasks.
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