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Home Industry News Lilly and AstraZeneca Alzheimer’s drug fast-tracked for approval in US

Lilly and AstraZeneca Alzheimer’s drug fast-tracked for approval in US

23rd August 2016

Lilly and AstraZeneca have announced that their new treatment for Alzheimer's disease has been fast-tracked for US regulatory review.

The US Food and Drug Administration has awarded fast track designation for the development programme in Alzheimer's disease for AZD3293, an oral beta secretase cleaving enzyme inhibitor currently undergoing phase III clinical testing.

It has been shown in studies to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer's and healthy volunteers, with a new study currently enrolling patients to assess its performance among people with mild Alzheimer's dementia.

Phyllis Ferrell, vice-president and global development leader for Alzheimer's disease at Lilly, said: "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."

AstraZeneca and Lilly have been working together on the development and commercialisation of AZD3293 since 2014.

Under the terms of the agreement, Lilly is leading the clinical development process, working with researchers from AstraZeneca's research and development team, while AstraZeneca will be responsible for manufacturing.

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