Researchers at Brigham and Women’s Hospital are standing athwart the current demand to speed up FDA approvals and saying that all the implications of doing so have not yet been weighed. In a study in the New England Journal of Medicine, they looked at a drug developed by Eli Lilly called solanezumab that did not work as hoped against Alzheimer’s, but did seem to show some benefit for a group of patients with mild dementia.
That was the finding after two clinical studies. Under some proposals to speed up FDA approval—which would now be allowed under the 21st Century Cures Act—that would be enough to put the drug on the market. Turns out, though, that the drug failed in the third clinical trial. The fact that solanezumab had not been approved because of that third clinical trial saved (on the assumption that it would have cost $10,000 per person) $10 billion over the next four years. Also, the hopes of some 260,000 people were not dashed.
The study states: “The failure of solanezumab offers a window into the U.S. drug regulatory system, particularly in the context of the 21st Century Cures Act and the national debate about the role of the FDA. The solanezumab story is an important case of a regulatory system that worked.”
Source: New England Journal of Medicine