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EU Recommends Approval of Lilly's Brain Plaque Test

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European regulators have recommended approval of an imaging test from Eli Lilly that can for the first time help doctors detect brain plaque tied to Alzheimer's disease.

The European Medicines Agency said on Friday that the radioactive dye, called Amyvid, could assist in the diagnosis of Alzheimer's, the most common form of dementia.

The green light in Europe follows an approval from the U.S. Food and Drug Administration in April.

Lilly's imaging agent binds to clumps of a toxic protein called beta amyloid that accumulates in the brains of patients with Alzheimer's. Doctors can then see the plaque light up on a positron emission tomography, or PET, scan.

There is currently no cure for Alzheimer's, a mind-robbing disease that affects more than 35 million people worldwide and gets worse with age.

But an early hint that something is wrong might improve the success of drugs meant to prevent or delay disease progression, researchers believe.

Lilly suffered a blow in August when its experimental drug for Alzheimer's disease, solanezumab, failed in two big studies to arrest declines in patients with mild to moderate symptoms.

However, its shares have jumped by around a fifth since then, largely due to indications from the studies that solanezumab might be able to slow the rate of cognitive decline in patients with mild Alzheimer's or those who have not yet developed symptoms.

Posted-In: News FDA


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