Levi Garraway (Genentech)

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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.