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.
"Based on both the independent analyses by the ADCS, as well as our own," said Eric Siemers, senior medical director of Lilly's Alzheimer's disease team, "we believe the results demonstrating a slowing of cognitive decline in patients with mild Alzheimer's disease treated with solanezumab are the first data from Phase 3 clinical trials that support the amyloid hypothesis."
"We remain encouraged and excited by the solanezumab data," said David Ricks, senior vice president and president, Lilly Bio-Medicines. "We are committed to working with the FDA and other regulatory authorities to bring solanezumab to the millions of patients and caregivers suffering from this devastating disease who urgently need this potential treatment."