Diabetes may be a widespread disease that millions of people need treatment, but a new analysis concludes that the development of new drugs has been a risky proposition for drug developers.
How is that? Here are some key findings:
Only 1 in 13 investigational drugs for diabetes that entered clinical trials 1995-2007 regulatory approval ultimately received, compared with 1 in 8 for all investigational drugs, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development.
The article continues after the announcement
The probability that a diabetes drug entering clinical trials testing would make the last stage was 13 percent, compared to 21 percent of all drugs. But the chances of approval of a drug for diabetes testing entered the last stage was 60 percent versus 56 percent for all drugs.
“There is a lot of demand (for new treatments), but this is a difficult market,” said Joseph DiMasi, director of economic analysis at the Center of Tufts, which is funded in part by drug manufacturers . It was noted that a high percentage of drugs for testing began after 2007 would still be in development, so the results could not be captured.
Undoubtedly, the results highlight the trends that have been quite remarkable in recent years, although the analysis appears to be the first attempt to quantify very specifically the changes seen through the prism of regulatory approvals .
Analysts say the most important for drug manufacturers reflected in the report challenge remains the regulatory approval process, which has become more demanding following a controversy in 2008 over heart risks a drug for diabetes widely used.
At that time, a meta-analysis determined the pill Avandia, which is marketed by GlaxoSmithKline, was responsible for an increased risk of heart attacks and strokes. This led to the FDA to place strict restrictions on Avandia and require other drug manufacturers to run additional tests for similar heart risks, which makes the process more uncertain, although the agency later backtracked and raised sidewalk in Glaxo pill after reassessing the meta-analysis.
“That (episode) moved the whole dynamic to get an approved drug,” David Kliff Diabetic Investor said. “The regulatory process has become more expensive since then, so the level of risk associated with the approval of new drugs is greater than it has ever been. That has not changed.”
Thus, the analysis of Tufts found that the so-called first-in-class approvals for diabetes – which refers to new types of drugs – accounts for nearly 30 percent of all FDA approvals. On the contrary, the first of its kind for other drugs endocrine disorders – those suffering thyroid or pancreas, among others – were 47 percent
In addition, all new diabetes drugs that were approved by the FDA from 1995 to 2015, 15 percent received a call priority review designation – which refers to a process faster review – compared to about 50 percent for other drugs [
There was at least one bright spot, however. 61 Diabetes and other endocrine drugs approved from 1995 to 2015 accounted for 10 percent of all new drugs approved by the FDA during that time.
This post has been updated to indicate the FDA later backtracked and lifted restrictions on Avandia.