Lilly Ends Trial Of BACE Inhibitor For Alzheimer’s, But Says Class-Wide Safety Effect Unlikely
With the termination of a Phase II trial of LY2887621, Merck’s MK-8931 leads the race to become the first BACE inhibitor approved for Alzheimer’s, although four other companies have similar candidates in earlier stages of development. Lilly says it may continue to pursue BACE inhibition in Alzheimer’s.
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The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.