Roche CEO Schwan puts 3-time Alzheimer's los­er gan­tenerum­ab back in the spot­light as FDA's con­tro­ver­sial Aduhelm OK in­spires block­buster fore­casts

Four years af­ter Roche opt­ed to res­ur­rect its late-stage ef­fort on their Alzheimer’s pro­gram for gan­tenerum­ab fol­low­ing a clear fail­ure, Roche CEO Sev­erin Schwan is sig­nal­ing some fresh en­thu­si­asm for its block­buster prospects in the wake of the con­tro­ver­sial Aduhelm OK.

Schwan told re­porters that com­pa­ny ex­ecs are en­gaged in on­go­ing talks with the FDA as spec­u­la­tion con­tin­ues to per­co­late around its chances based on bio­mark­er da­ta alone, now that reg­u­la­tors have es­tab­lished a prece­dent us­ing an ac­cel­er­at­ed ap­proval path­way process with no con­vinc­ing ev­i­dence of ef­fi­ca­cy in help­ing pa­tients re­tain their cog­ni­tive skills. In Aduhelm’s case, the drug re­duced the amount of amy­loid in the brain and Bio­gen was able to win the ac­cel­er­at­ed ap­proval on what the FDA called a rea­son­able ex­pec­ta­tion of suc­cess.

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