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FDA Approves Lilly's Amyvid

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The US Food and Drug Administration (FDA) recently approved Eli Lilly and Company’s (LLY - Free Report) radioactive diagnostic agent, Amyvid (florbetapir F 18 Injection). Amyvid has been designed to help detect the density of beta-amyloid plaques in patients (with cognitive impairment) who are being evaluated for Alzheimer's disease and other causes of cognitive decline.

While a negative scan would mean little to no amyloid plaques are present, a positive scan would point towards the presence of moderate to frequent plaques. It is to be noted that while moderate to frequent plaques are usually found in patients with Alzheimer’s, the same may also be in the case of patients with other neurologic conditions or in elderly people with normal cognition.

Amyvid became a part of Eli Lilly’s portfolio with its December 2009 acquisition of privately-held company, Avid Radiopharmaceuticals, Inc. In March 2011, Amyvid had received  a complete response letter (CRL) from the FDA. Prior to the CRL, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had voted against granting approval to Amyvid based on the submitted data.

In its CRL, the FDA had said that Eli Lilly needs to implement a reader training program which will help ensure accurate and consistent interpretation of existing Amyvid scans.

Our Take

Amyvid’s approval should provide Eli Lilly with a near-term revenue source. Moreover, it should fit well in Eli Lilly’s product portfolio as the company itself has been pursuing the development of treatments for Alzheimer’s disease. Meanwhile, Amyvid’s approval provides physicians an additional tool that can be used with other diagnostic options to evaluate a patient.

The worldwide Alzheimer’s disease market represents huge commercial potential with companies like Pfizer (PFE - Free Report) and Johnson & Johnson (JNJ - Free Report) working on developing treatments for the disease. Eli Lilly currently has a phase III Alzheimer’s disease candidate, solanezumab, in its pipeline.

We currently have a Neutral recommendation on Eli Lilly, which carries a Zacks #3 Rank (short-term Hold rating).

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