Peanut Patch Breaking Forward!

Dr Benhamou’s excitement is contagious. I just want to raise up my glass of soy milk and cheer that a food allergy therapy has achieved the impressive Food and Drug Administration (FDA) Designation of Breakthrough Therapy– a fete that I have never seen before in our world of life threatening food allergies!  Dr. Pierre-Henri Benhamou, CEO of DBV Technologies and inspiration for Viaskin® Peanut Patch shared with me, “We hope this status will bring this promising therapy to patients as quickly as possible.”
This is an understatement!  After my past interview with Dr. Benhamou, I realized that his passion and excitement is on par with our passion as food allergic parents trying to keep those we love safe.  “This is an historical event for peanut allergy patients, caretakers and clinicians that have long awaited for a treatment for this severe disease,” Dr. Benhamou explained in the DBV Technologies press release yesterday.
What does this status of FDA Breakthrough Therapy mean to you and I exactly?  First, the Viaskin® Peanut Patch has already received Fast Track Status–which means the approval process of review is basically like driving in the car pool lane on the freeway – you are on the same path, just moving along quicker towards your destination.
The Breakthrough Therapy designation reflects the FDA’s belief that this therapy is significant and needs to be fast tracked on that Fast Track!  It is only given to drugs that might provide therapy solutions to serious or life threatening conditions.  Simply put, the FDA believes that this drug might provide significant value and should be on the path for accelerated approval and priority review.  The FDA receives many requests for drug approval, so this is their process to quickly get life changing drugs accessible to those of us in need!
To show you how amazing this is: in 2014, the FDA received 96 requests for Breakthrough Therapy status.  Fifty one were denied with only 31 receiving the much desired designation!  Yes, this is very important news to our peanut allergic world.  This means that the odds are even higher that the Viaskin® Peanut Patch will truly make its way to us consumers.  The FDA will also offer “more intensive guidance on an efficient drug development program” as per the FDA’s description.
Dr. Benhamou explained to me, “this Breakthrough Therapy Designation granted for Viaskin® Peanut is an encouragement from FDA to pursue our development, and also derisk a lot in the next step in our development, like protocol, the trial design and the way Viaskin® is developed.”  
This news is not only exciting and important, it is the signal of the new era of solutions to me.  I’ve been managing life threatening food allergies in my family for almost 15 years now.  I truly never believed that I would ever see the day that my son would have options and safely head to college and into his future. Disclaimer: I’m a bit more emotional than normal since we are wrapping up this leg of our college tours.  I can’t believe my little food allergic toddler has grown into a young man, with only four allergens left from his previous his long allergen list, and is planning the next steps of life and exploration.  Even more stunning, is that we might have a therapy for him to review!
Congratulations Dr. Pierre-Henri Benhamou and DBV Technologies for your hard to try to find solutions to our challenging invisible and life threatening condition.  I hope to hear more good news in the future!