FDA issues complete response letter for Amyvid NDA: Eli Lilly, Avid
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Eli Lilly and its wholly owned subsidiary, Avid Radiopharmaceuticals related to their new drug application (NDA) for Amyvid (florbetapir F 18 injection).
Avid, a wholly-owned subsidiary of Eli Lilly. Lilly acquired Avid Radiopharmaceuticals in December 2010.
Amyvid is a molecular imaging agent under investigation for Positron Emission Tomography (PET) imaging of beta-amyloid plaque in the brain.
Avid claims that Amyvid is its lead candidate and was the first beta-amyloid imaging compound to enter multi-center, investigational new drug (IND) clinical studies in the US.
Lilly brand director for Amyvid Wei-Li Shao said Lilly and Avid have been engaged in an active and ongoing dialogue with the FDA. They remain confident in the data submission package for Amyvid,"
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