EU signs off on Lilly's Amyvid, its diagnostic test for Alzheimer's

While Eli Lilly struggles with development of its therapy for treating Alzheimer's disease, its diagnostic imaging agent for helping diagnose, or rule out, the condition has gotten another approval, this time in Europe.

Lilly ($LLY) announced today that EU regulators have approved Amyvid with PET imaging for use in adult patients who are being evaluated for Alzheimer's disease and other cognitive conditions. The tool measures the level of plaque in the brain, which is associated with Alzheimer's. Before, the plaques were only evident during an autopsy. Lilly points out that one in 5 patients who receive a diagnosis of probable Alzheimer's are not found to have the plaques during an autopsy. The FDA approved the test last April.

Using Amyvid can help doctors rule out the disease so "a physician can avoid unnecessary or potentially harmful treatments associated with a misdiagnosis of Alzheimer's disease," said Diane Bakaysa, Amyvid global brand development leader.

Lilly is also working on solanezumab, a drug it hopes will treat the disease. Last month, however, the company said that after meetings with top regulators, it would not file for U.S. approval of the closely watched Alzheimer's candidate. Instead, Lilly said it would begin a new Phase III study. Lilly's two late-stage trials of the treatment this summer came up short on measures of cognitive and functional status in patients with mild-to-moderate Alzheimer's disease. Data from patients with mild disease, however, showed a 34% reduction in cognitive decline, leaving Lilly with some hope for the therapy.

- here's the release

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