FDA Grants Fast Track To Eli Lilly And AstraZeneca’s Alzheimer’s Drug

A drug designed to treat patients in the early stages of Alzheimer’s disease has been granted a fast track designation by the US Food and Drug Administration (FDA). The drug – developed by Eli Lilly and AstraZeneca – is a beta secretase cleaving enzyme (BACE) inhibitor that is currently being assessed in Phase III clinical trials.

“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,” said Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Eli Lilly. “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.”

The FDA’s fast track program helps accelerate the review of new drugs which have the potential to fill a gap in the therapeutic market. The BACE inhibitor, AZD3293, has shown promise in reducing amyloid beta levels in the cerebrospinal fluid of healthy volunteers and Alzheimer’s patients.

As the accumulation of amyloid beta is a hallmark of Alzheimer’s pathology, AZD3293 is designed to reduce levels of an enzyme, BACE, which is involved in amyloid beta formation. A continuing Phase II/III clinical trial called AMARANTH is ongoing to test the efficacy of this BACE inhibitor.

“The Fast Track designation in the U.S. for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE alliance to help advance science for patients and their families managing this devastating illness,” said Craig Shering, AZD3293 Project Lead in Global Medicines Development at AstraZeneca. “BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today.”

Eli Lilly and AstraZeneca have also announced that they plan to start an additional Phase III clinical trial for AZD3293. The DAYBREAK-ALZ study – which started to enroll participants earlier this year – will investigate the safety and efficacy of the BACE inhibitor in patients with mild Alzheimer’s dementia.