The newest study is expected to get under way in the third quarter of 2013 and will focus on patients with mild Alzheimer’s disease. It comes after Lilly released results of two clinical trials in August that showed the drug, called solanezumab, did not significantly improve either the cognition or daily functioning of people with mild and moderate forms of the disease. But despite that failure, the results also showed some reason for hope: when patients with mild Alzheimer’s were separated out, the drug was shown to significantly slow their decline in cognition.
In a statement Wednesday, the company said it decided not to pursue approval of the drug based on existing study results after it met with officials from the Food and Drug Administration. However, a Lilly executive said the company was still optimistic.
“We remain encouraged and excited by the solanezumab data,” David Ricks, a senior vice president at Lilly and president of Lilly Bio-Medicines, said in the statement. “We are committed to working with the F.D.A. 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.”
The Lilly drug is the second Alzheimer’s drug to fail in clinical trials this year. Pfizer and Johnson Johnson stopped development of a similar treatment, bapineuzumab, after it also was not shown to work. Both drugs target beta amyloid, a protein in the brain that is found in people with Alzheimer’s disease.
Lilly shares were down about 3 percent, to $49.05, by midmorning.
Article source: http://www.nytimes.com/2012/12/13/business/eli-lilly-to-conduct-additional-study-of-alzheimers-drug.html?partner=rss&emc=rss
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