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3 New FDA Breakthrough Therapies: 2 For Merck’s HCV Combo, 1 For DBV Technologies’ Peanut Allergy Patch

April 10, 2015



This Blog Post reviews 3 new FDA Breakthrough Therapy Designations (BTDs) that are granted in the past several days:

·   Merck’s Grazoprevir/Elbasvir combination for Chronic Hepatitis C Genotype 4

·   Merck’s Grazoprevir/Elbasvir combination for Chronic Hepatitis C Genotype 1 with end-stage renal disease on hemodialysis

·   DBV Technologies’ Viaskin Peanut.

I – Merck’s Grazoprevir/Elbasvir Combination For Hepatitis C

In October 2013, Merck receives the FDA BTD for the Grazoprevir/Elbasvir combination for chronic Hepatitis C (HCV) Genotype1. Then in January 2015, the FDA notifies Merck of its intention to “rescind” that BTD. Grazoprevir/Elbasvir is an investigational, once-daily single tablet regimen consisting of Grazoprevir (NS3/4A protease inhibitor) and Elbasvir (NS5A replication complex inhibitor).

On April 8th, the FDA grants 2 NEW BTDs for the Grazoprevir/Elbasvir combination:

•   Chronic HCV Genotype 4

•   Chronic HCV Genotype 1 with end-stage renal disease on hemodialysis.

At this month’s meeting, The International Liver Congress 2015, Merck will be presenting 14 abstracts from studies evaluating Grazoprevir/Elbasvir.

II – DBV Technologies’ Viaskin Peanut

DBV Technologies, a French clinical-stage specialty biopharmaceutical company, announces April 9th that the FDA grants the BTD to Viaskin Peanut for children with peanut allergies. It is the first BTD for a food allergy and also receives FDA Fast Track Designation.

Viaskin is an electrostatic patch:

“ … which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the blood stream … thus considerably lowering the risk of a systemic, allergic reaction in the event of accidental exposure.”

Currently, DBV is actively preparing the launch of its Phase III trial of Viaskin Peanut in children, suffering from peanut allergy, in close coordination with the FDA. DBV Technologies is also developing Viaskin Milk for milk allergy.



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “White Pocket Reflection” by John Fowler (Flickr: White Pocket Reflection) [CC BY 2.0] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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