Lilly's (LLY) Amyvid Receives Positive CHMP Opinion in the EU
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Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced they received 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 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.
The positive opinion is now 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.
The positive opinion is now 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.
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