July 16, 2015

FDA Report on Targeted Drug Development: The Diabetes Section

Are you a policy geek? FDA has a white paper out on drug development and it has some background on diabetes (T1 and T2) and how they go about drug approval.

It isn't page turner like Game of Thrones (GoT) but hey let be honest GoT books 4 and 5 dragged on.  

Here is the preface of what they say about diabetes and a link to the section of the white paper on diabetes:
..our understanding of disease causation and progression is sufficient to permit our use of certain tools such as surrogate endpoints. But it is insufficient to develop others such as biomarkers to help target specific subset of patients who are less likely to suffer side effects from specific drugs. Even where scientific research has not yet identified the molecular and genetic bases for a disease and its treatment, FDA is using tools other than targeting and biomarkers to reduce the length and cost of clinical trials, including flexible trial designs, expedited development pathways, public-private research collaborations, and intensive engagement with drug sponsors. In addition, these tools can support the development of one of the most promising avenues for accelerating drug development: targeted, or precision, medicine—the ability to target the right drug to the right patient based on understanding of the genetic and biochemical basis of a disease in patient subgroups.
Diabetes : http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm454955.htm#Diabetes

Have fun reading geeks.

The reader digest version is summed up in these quotes:
  • FDA has long allowed manufacturers to show that a diabetes drug works by using a simple surrogate endpoint—lowering blood sugar. 
  • There have been longstanding concerns that some drugs for type 2 diabetes that successfully lower blood sugar may nevertheless increase rather than decrease the risk of heart attack.
  • To minimize the impact on innovation while ensuring acceptable cardiovascular safety, FDA asks for preliminary CV safety data before approval and for detailed additional data to characterize CV effects after the product is on the market.
  • FDA has approved seven new diabetes drugs in the last two years. This includes three drugs that represent entirely new drug classes—a measure of how innovative these drugs are. In June 2014, FDA approved the only inhaled insulin product. The diabetes drug pipeline is among the strongest for any disease category and includes potentially transformative advances for type 1 diabetes.
 Yeah there is more in there. If you like wanting around in Westeros, enjoy the read.