Developers with experimental diabetes drugs in the pipeline will have to go an extra mile in R&D to win an FDA approval. In a move sure to add a significant amount of expense to the development process, the FDA is mandating more screening of potential heart risks.
The AP notes that there are more than 100 new diabetes drugs in the biopharma pipeline. Developers are racing to add new therapies that will help treat more than 23 million Americans with Type 2 diabetes. But before they get a green light from the agency, they'll need to offer up a bigger set of safety data. Dr. Mary Parks says the new standard is needed to remove a high level of uncertainty that surrounds drugs in this field.
"The idea is not to create such a high barrier that you will stifle innovation in developing new drugs, but to make sure clinicians have the information they need," Steve Nissen, a renowned Cleveland Clinic cardiologist, told the AP. "This will raise the level of evidence available, and that is good for patients."
- read the report in the Washington Post