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Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET) imaging agent flortaucipir F-18 met its two primary endpoints, defined as predicting brain tau pathology and predicting Alzheimer's disease diagnosis.
The Alzheimer's Association is disappointed by the Centers for Medicare & Medicaid Services (CMS) decision to allow only Coverage with Evidence Development (CED) for an Alzheimer's imaging test that would improve diagnostic accuracy and certainty in challenging cases. When used in specific populations, as outlined in criteria developed by the Alzheimer's Association and the Society for Nuclear Medicine and Molecular Imaging (SNMMI), this tool has the potential to help identify amyloid in the brain, a hallmark of Alzheimer's disease, and resolve distressing medical uncertainty.
Eli Lilly and Company and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced today that Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.[1]
With 2013 on the horizon, ITN looks to see what issues and trends are likely to be prominent for medical imaging in the coming months. Industry experts from several professional societies and organizations gave their input about topics that will be at the forefront in 2013 and their expected impact across major industry segments.
June 4, 2012 — Eli Lilly and Co. and Avid Radiopharmaceuticals Inc., a wholly owned subsidiary of Lilly, announced that Amyvid is available to imaging centers in markets surrounding 16 manufacturing sites located in Atlanta; Charlotte, N.C.; Chicago; Colton, Calif.; Columbus, Ohio; Dallas; Fort Lauderdale, Fla.; Hartford, Conn.; Houston; Jacksonville, Fla.; North Wales, Pa.; Orlando, Fla.; Palo Alto, Calif.; Phoenix; Seattle; and St. Louis.
The U.S. Food and Drug Administration (FDA) has approved the first diagnostic agent to image Alzheimer’s disease beta-amyloid neuritic plaques in the living brain. Previously, the only way to confirm diagnosis of these plaques was from post-mortem biopsies. Eli Lilly and Company and Avid said the FDA cleared the commercial release of florbetapir (Amyvid).
November 9, 2011 – PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA Inc., has entered into a nationwide commercial agreement with Eli Lilly and Company that grants Siemens PETNET Solutions the right to manufacture and distribute Lilly’s molecular imaging agent, which is currently under review by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging.
April 4, 2011 – The U.S. Food and Drug Administration (FDA) has given a complete response letter to Eli Lilly and its subsidiary, Avid Radiopharmaceuticals, regarding the new drug application (NDA) for Amyvid (florbetapir F 18 injection). Amyvid is a Positron Emission Tomography (PET) imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.