Lillya[euro](tm)s Amyvid Amyvid (Florbetapir F 18) solution recommended for approval in Europe as a diagnostic tool for PET Imaging of Beta-Amyloid Plaque Density.
M2 EQUITYBITES-October 22, 2012-Lillya[euro](tm)s Amyvid Amyvid (Florbetapir F 18) solution recommended for approval in Europe as a diagnostic tool for PET Imaging of Beta-Amyloid Plaque Density(C)2012 M2 COMMUNICATIONS http://www.m2.com
Pharmaceutical products company Eli Lilly and Company (NYSE:LLY) and its wholly owned subsidiary Avid Radiopharmaceuticals Inc announced on Friday the receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, recommending approval of Amyvid (Florbetapir F 18) solution for injection as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density.
Amyvid is a radioactive diagnostic agent indicated for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline.
According to the companies, Amyvid should be used in conjunction with a clinical evaluation.
The positive opinion will now be referred for final action to the European Commission, which has the authority to approve medicines for the European Union (EU). The commission usually decides on CHMP recommendations within three months.
Amyvid for intravenous use was approved by the US Food and Drug Administration (FDA) in April 2012 and is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Oct 22, 2012|
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