Eli Lilly and Co. have announced another study for solanezumab, a drug it has developed to treat Alzheimer's. The drug, which helps to rid protein plaques thought to be a major influence on the development of mental decline, faired well in initial tests, the results of which were released in early October.
Investors had hoped somewhat optimistically that approval from the FDA would be forthcoming based on the positive study results, however, after meeting with the agency, Lilly has decided to halt approval for it.
When taken at the onset of the disease, solanezumab effected a roughly 30% decrease in mental decline compared with a placebo.
"Based on both the independent analyses by the ADCS, as well as our own," Eric Siemers, senior medical director of Lilly's Alzheimer's disease team, says in a statement.
"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 III clinical trials that support the amyloid hypothesis."
The Phase III trial is set to begin no later than the third quarter of 2013, finish by mid-2015—a timetable suggesting a launch sometime in 2016.
Industry insiders expect approval of the drug would lead to sales in the $5 to $10 billion range.
by RTT Staff Writer
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