Hep C Discussion Forum

Wanted to clarify the possible time line for Sofosbuvir & Ledipasvir to be available to Patients.

After reading the FDA web site about how NDA (New Drug Applications) are processed I was somewhat confused on the timing issue. The Standard review time is 10 months but the Priority review time is cut to 6 months. What I have learned is when the NDA in applied for the drug company can request a priority review but the FDA has 60 days to rule on the request.

In the case of Gilead's NDA for Sovaldi (Sofosbuvir) they requested on April 8, 2013 but didn't received priority review designation until June 7, 2013  and was finally approved on Dec.6, 2013  so it was 8 months total from Gilead's NDA date.

So we wait, with Dec 9 being the very latest date and Sept 9 or Oct 9 being the same window of time that Sofosbuvir had. Hopefully the FDA will see the need to give Priority review based on the demand that an all oral treatment that has showed is needed. This of course assumes that Gilead requested priority review on the combo. 

Here the link to the FDA article about how drugs are designated

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm

I realize that knowing these dates can be very important in planing for treatment and determining whether to treat now or wait. Another consideration can to do with Insurance and the deductible that has to be met and it's typical renewal date on Jan 1, 2015 because most insurance dispense these specialty drugs on a monthly basis if the treatment bridges between years some insurance companies make you repay the yearly deductible again. So depending on your length of treatment and when you start treatment it needs to be considered.        

matt