Eli Lilly (LLY) agreed to conduct an additional late-stage study of its Alzheimer’s disease drug solanezumab on Wednesday, pushing back plans to file for U.S. and European approvals.
The Indianapolis-based drug maker will undergo another Phase III patient trial of the highly-watched drug in 2013 in an effort to prove that it does reduce cognitive decline and memory loss in patients with mild-to-moderate Alzheimer’s disease.
Lilly said it would still consider seeking approval for the drug in markets outside the U.S., however its shares slumped 3% Wednesday as investors digested the disappointing realization that it could be another few years before the potential blockbuster is available in the U.S.
Two late-stage trials from earlier this year failed to meet primary efficacy goals, but Lilly nevertheless called them encouraging, saying data pooled from the results suggested a slowdown in cognitive decline in people with early stages of the disease.
However, market experts said Lilly would likely have to undergo another trial to shore up doubts, and based on recent meetings with regulators, the pharmaceutical giant decided it would conduct another test before it seeks U.S. Food and Drug Administration approvals.
Lilly said it will continue to analyze and discuss the data with regulators to determine a regulatory path for solanezumab and expects to begin the test no later than the third quarter of 2013.
“We remain encouraged and excited by the solanezumab data," said David Ricks, senior vice president of 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."
Alzheimer’s disease, which causes progressive decline in memory and other aspects of cognition, affects 35.6 million people in the world and is estimated to grow to more than 115 million by 2050. The exact cause of the disease is unknown and there are currently no approved treatments shown to slow its progression.