December 16, 2011

December 16, 2011
Gilead Files sNDA for Truvada for PrEP

Welcome to another day in my life. Today is Friday and we have almost made it through another work week. I hope you have been having a safe and great week so far. It has been another busy week for Dab the AIDS Bear and me.

I am pleased to inform you that today Gilead submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application for once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV.

In addition to the positive Phase 3 data from several clinical studies evaluating Truvada for PrEP, the decision to file for this expanded indication was informed by the guidance and insight that you and others so generously provided in our recent consultative meetings.

Because of the potential public health benefit, we have requested a priority review on this application. If granted, a priority review could result in a decision from FDA by June 2012. We also anticipate that the FDA may convene an Advisory Committee Meeting in the spring of 2012 to assess the merits of our application. Such a meeting would typically involve community representatives and provide an opportunity for public commentary.

Please let me know if you have any questions; we will keep you updated as we learn more about the regulatory timeline regarding Truvada for PrEP. Thank you very much, once again, for your time and input regarding this important issue.

It is going to be another busy weekend for Dab the AIDS Bear and me. So if you see up in your city be sure to say hello and get your picture taken with Dab the AIDS Bear in support of people living with HIV and AIDS.

Hope you have a safe and great Friday!

Until we meet again; here's wishing you health, hope, happiness and just enough.

big bear hug,

Daddy Dab