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FDA Breakthrough Therapy Designation: Bristol-Myers Squibb Gets #34

February 24, 2014


On February 24th, Bristol-Myers Squibb (BMS) announces that the FDA Breakthrough Therapy Designation (BTD) is granted for the treatment of genotype 1b chronic Hepatitis C (HCV), for the company’s investigational all-oral combination therapy of :

• Daclatisvir (DCV), an NS5A replication complex inhibitor

• Asunaprevir (ASV), an NS3 protease inhibitor.

The BTD is based on data from BMS’ ongoing Phase III clinical trial program that is evaluating the all-oral combination regimen of DCV + ASV, without ribavirin. This is the 34th BTD that is announced by a sponsor company and the third BTD for 2014. It is the second BTD BMS receives for a DCV-based regimen for the same indication :

Row Num Drug Name Indication


3-drug regimen Hepatitis C


Daclatasvir       + Asunaprevir Hepatitis C


It is in 2013, that BMS announces that the FDA grants a BTD for an experimental, three-drug regimen for hepatitis C. The triple Direct-Acting Antiviral (DAA) combo includes :



• BMS-791325, an NS5B non-nucleoside polymerase inhibitor.

Of the 34 FDA BTDs identified by sponsor companies (as of 02/24/14), 6 or 18% are for Hepatitis C, with Sovaldi receiving FDA approval in December 2013:

Row Num

Drug Name

Sponsor                                               Company


3-drug regimen Bristol-Myers Squibb


3-drug combination AbbVie


Sofosbuvir                     +Ledipasvir                   Gilead Sciences


MK-5172/MK-8742 Merck


Sofosbuvir (Sovaldi) Gilead Sciences


Daclatasvir       + Asunaprevir Bristol-Myers Squibb




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “IMG Carlingford Lough 0617” by By Sarah777 at en.wikipedia [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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