New trial planned for solanezumab (Eli Lilly) for mild Alzheimers Disease treatment
Eli Lilly and Company has provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase III study of solanezumab in patients with mild Alzheimer's disease. Additional details, including study design and length, are still being determined.
Lilly expects to initiate this study no later than Q3 2013. Based on recent meetings with the FDA, Lilly does not intend to submit a Biologics License Application (BLA) at this time in the U.S. based solely on the existing analyses of data from the EXPEDITION studies.
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