FDA approves GE’s imaging drug Vizamyl for Alzheimer’s

October 28, 2013 | By Anabela Farrica

Last Friday, FDA approved Vizamyl (flutemetamol F 18), a radioactive agent to be used with PET to help evaluate the brain of patients for Alzheimer’s disease or dementia. Vyzamil works by binding to beta-amyloid plaques, which can be found in the brain of people with Alzheimer’s disease or other dementias, as well as in the brain of elderly people who do not have neurological problems.

Vyzamil was designed to be injected intravenously before a PET scan in adults being scrutinized for the aforementioned conditions. According to the FDA press release, a negative scan is one in which little plaque is found, thus leading to the conclusion that Alzheimer’s is not the underlying cause of dementia. A positive scan is one in which a considerable amount of plaque is found, but it does not allow for a definite conclusion regarding the diagnostic of Alzheimer’s. Vyzamil is not meant to replace the diagnostic tools currently used in the evaluation of AD and other dementias, but rather to aid physicians in identifying a patient’s cause of cognitive decline.

Trials used to assess Vizamyl’s effectiveness demonstrated that this radioactive substance correctly detects beta amyloid in the brain, originating reproducible scans, which can be accurately read and interpreted by trained physicians. Major side effects of Vizamyl include dizziness, nausea and headaches.

Vizamyl is manufactured for GE Healthcare by Medi-Physics, Inc., and it was licensed to Merck for use on select trial participants for MK-8931, Merck’s hoped-for Alzheimer’s blockbuster drug. This is the second drug FDA has approved to help screen for Alzheimer’s, following the approval of Eli Lilly’s Amyvid in April 2012.




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