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Eli Lilly, AstraZeneca Alzheimer's Drug Gets FDA Fast Track

Arpita Dutt
Updated

Eli Lilly and Company LLY and AstraZeneca plc AZN gained fast track status in the U.S. for their experimental Alzheimer’s disease (AD) treatment, AZD3293.

AZD3293 is a BACE inhibitor that is currently in phase III studies. In addition to being in a phase II/III study (AMARANTH), patients are being enrolled in a phase III study (DAYBREAK-ALZ) that is evaluating the safety and efficacy of AZD3293 in people with mild Alzheimer's dementia.

We note that the FDA grants Fast Track status to facilitate the development and speed up the review process for candidates that are being developed for the treatment of serious conditions with an unmet medical need.

While the successful development of therapies for the treatment of Alzheimer’s disease is challenging, the market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.

According to information provided by Lilly in its press release, about 46 million people are living with dementia across the world, with the number expected to cross 74 million in 2030 and 131 million in 2050.

Lilly has another Alzheimer’s disease candidate in its pipeline – solanezumab, an anti-amyloid beta monoclonal antibody in phase III development for the treatment of preclinical and mild Alzheimer’s disease.

LILLY ELI & CO Price

LILLY ELI & CO Price | LILLY ELI & CO Quote

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Lilly and AstraZeneca’s alliance for the development and commercialization of AZD3293 goes back to 2014.

ASTRAZENECA PLC Price

ASTRAZENECA PLC Price | ASTRAZENECA PLC Quote

Lilly and AstraZeneca are both Zacks Rank #3 (Hold) stocks. Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF and Zoetis Inc. ZTS – while Actelion is a Zacks Rank #1 (Strong Buy) stock, Zoetis is a Zacks Rank #2 (Buy) stock.

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ASTRAZENECA PLC (AZN): Free Stock Analysis Report
 
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