AstraZeneca and Lilly' Alzheimer's candidate fast-tracked by FDA

22 August 2016

AstraZeneca (LSE: AZN) and Eli Lilly (NYSE: LLY) have received US Food and Drug Administration fast-track designation for the development program in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial.

The FDA’s Fast Track program is designed to expedite the development and review of new therapies to treat serious conditions and tackle key unmet medical needs.

Under the terms of a 2014 agreement, Lilly undertook to pay AstraZeneca up to $500 million in development and regulatory milestone payments. The companies share all costs equally for the development and commercialization of AZD3293, as well as net global revenues post-launch. Lilly is continuing its work in the Alzheimer's space, despite some major setbacks, including dropping its own BACE program for the disease - LY2886721 - after investigators linked it to toxicity in liver tests.

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