Eli Lilly and Company LLY today provided an update on
the next steps planned for solanezumab, its Phase 3 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 3 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 U.S. Food and Drug Administration (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. Lilly will continue to analyze and discuss the data from
the two, Phase 3, double-blind, placebo-controlled solanezumab EXPEDITION
studies with regulators globally to determine the regulatory paths forward in
different regions. It is possible that different courses of action could be
taken in different jurisdictions.
Independent analyses of the Phase 3 solanezumab EXPEDITION data were conducted
by the Alzheimer's Disease Cooperative Study (ADCS), an academic research
consortium, and presented at the annual meeting of the American Neurological
Association (ANA) on Oct. 8, 2012, and at the Clinical Trial on Alzheimer's
Disease (CTAD) meeting on Oct. 29, 2012.
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