FDA fast tracks Alzheimer’s drug from Lilly, AstraZeneca
pharmafile | August 22, 2016 | News story | Manufacturing and Production, Research and Development | Alzheimer's disease, AstraZeneca, BACE, lilly, phase III
AstraZeneca and Eli Lilly have announced that the US Food and Drug Administration (FDA) has granted AZD3293 its fast track designation for the treatment of Alzheimer’s disease.
AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor which attempts to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer’s. BACE is an enzyme associated with the development of amyloid beta and it is believed that the accumulation of amyloid plaque in the brain is a key driver of disease progression.
AZ and Lilly continued Phase III trials for the drug candidate in April, after an independent monitoring committee recommended the study’s continuation.
Phyllis Ferrell, vice president and global development leader for Alzheimer’s at Lilly, says: “We are pleased the FDA places a high priority on the development of drugs that target Alzheimer’s disease, one of the most critical health issues of our time. Most importantly, this is a positive step forward for the millions of patients, families, caregivers, advocates and healthcare providers who fight every day for progress.”
Craig Shering, project lead for AZD3293 at AstraZeneca, says: “The fast track designation in the US for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE Alliance to advance science for patients and their families managing this devastating illness. BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today.”
Sean Murray
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