A few days ago, the Food and Drug Administration (FDA) granted fast track status to a new potential drug to help people with Huntington's Disease. This drug currently named as OMS824 is an inhibitor that can help to suppress one of the enzymes in the brain that has been linked to Huntington's Disease. That got me excited. And makes me wonder what exactly that means. Thank you Google for making it easier to research and find the answers.
The FDA's Fast Track program designates a drug as a fast track drug "if it is intended, whether alone or in combination with one or more drugs, for the treatment of a serious or life-threatening disease or condition AND it demonstrates the potential to address unmet medical needs for such a disease or condition." according to the FDA's website. We have already established that HD is a serious and life-threatening disease for which there is no cure. So, it meets the first criteria for Fast Track Status. In initial tests, OMS824 has shown to effectively inhibit the production of an enzyme that is linked to HD. That sounds like it meets a current unmet need for those living with HD. So, thank you to the FDA for realizing this and granting Fast Track Status.
The fast track designation means that it is given more access to the FDA for the sole purpose of speeding up the development of the drug. There is more interaction with FDA review team for the product including more frequent meetings to discuss the development of the drug and more communications from the FDA about the design of the trails and what can and cannot be used.
In a nutshell, from what I have been able to find out, is that a fast track designation will make it easier for the company that is developing the potential drug to interact with the FDA and make sure it is meeting and maintaining all of the appropriate criteria to allow continued development of the drug. So, it might speed up the whole process of getting this new drug tested and to market if the clinical trails are as successful as everyone hopes.
It can still take a few years for all of this to happen but it may be even closer than we think. I think it also means that science is getting closer and I am really hopeful of seeing something to end this horrific disease in my lifetime.
