Eli Lilly and Company and AstraZeneca announced they have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer's disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials.

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

"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 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 Fast Track designation in the US 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."

In addition to the continuing AMARANTH phase 2/3 study, Lilly and AstraZeneca have also announced the planned initiation of a second phase 3 trial for AZD3293. The trial, called DAYBREAK-ALZ, studies the safety and efficacy of AZD3293 in people with mild Alzheimer's dementia and began enrolling participants in the third quarter of 2016.

AZD3293 has been shown in studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer's and healthy volunteers. The progression of Alzheimer's disease is characterized by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation and build-up of amyloid plaque which in turn may help slow the progression of the disease.

AstraZeneca and Lilly announced an alliance in 2014 for the development and commercialization of AZD3293. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca's research and development team, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of the molecule and will share all future costs equally for development and commercialization, as well as net global revenues post-launch.

Alzheimer's disease is a fatal illness and is the most common form of dementia, accounting for 60 to 80 percent of cases. There are currently an estimated 46 million people living with dementia worldwide, and this number is expected to exceed 74 million in 2030 and 131 million in 2050. Only 50 percent of people with dementia ever receive a formal diagnosis, and Alzheimer's disease continues to be one of the most significant health challenges facing the world. The total estimated worldwide cost of dementia in 2015 was $818 billion. By 2018, dementia will become a trillion dollar disease, rising to $2 trillion by 2030.