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AbbVie Receives FDA Breakthrough Therapy Designation For Hepatitis C

May 8, 2013

AbbVie announces on May 6, 2013, that the FDA has given the Breakthrough Therapy Designation to the company’s non-orphan, all-oral triple Direct-Acting Antiviral (DAA) combination, with and without ribavirin, for genotype 1 (GT1) Hepatitis C (HCV). The triple Direct-Acting Antiviral (DAA) combo includes :

•   ABT-450/r (protease inhibitor and ritonavir)
•   ABT-267 (NS5A inhibitor)
•   ABT-333 (non-nucleoside polymerase inhibitor).

The FDA designation is based on positive data from a Phase IIb trial, Aviator, conducted in 571 patients infected with GT1 HCV. Results from the Aviator study are presented at the European Association for the Study of the Liver Congress in April in Amsterdam :

•   After 12 weeks of therapy, 99% of treatment-naïve patients achieve Sustained Viral Response rates (SVR)
•   After 12 weeks of therapy, 96% achieve SVR24.

The triple combo  is now entering a Phase III program which includes more than 2,000 patients with GT1 HCV.

Just over a week ago on April 25, 2013, Bristol-Myers Squibb’s HCV triple Direct-Acting Antiviral (DAA) combination of Daclatasvir Asunaprevir, and BMS-791325, receives the FDA Breakthrough Therapy Designation (reference Blog Post).

12 Breakthrough Therapy Designations

The 12 Breakthrough Therapy Designations granted for drugs that have been identified by the sponsor companies (as of 05/08/13) are as follows :

•   Two are awarded to Vertex Pharmaceuticals for expanding the uses of its Cystic Fibrosis orphan drug Kalydeco
•   Three are awarded to Pharmacyclics and Janssen Research & Development for the cancer therapy drug Ibrutinib for relapsed or refractory Mantle Cell Lymphoma (MCL – orphan designation), Waldenstrom’s Macroglobulinemia (WM), and Chronic Lymphocytic Leukemia (CLL – orphan designation) or Small Lymphocytic Lymphoma (SLL) with deletion of the short arm of chromosome 17
•   One is awarded to Novartis for cancer non-orphan drug LDK378 for ALK+ Non-Small Cell Lung Cancer
•   One is awarded to Pfizer for breast cancer non-orphan drug Palbociclib
•   One is awarded to Merck for cancer non-orphan drug Lambrolizumab for Melanoma
•   One is awarded to Bristol-Myers Squibb for experimental, non-orphan three-drug regimen for Hepatitis C
•   One is awarded to Scioderm for investigational non-orphan product SD-101 for Epidermolysis Bullosa (EB)
•   One is awarded to Genmab and Janssen Research & Development for non-orphan drug Daratumumab for Multiple Myeloma
•   One is awarded to AbbVie’s non-orphan three-drug combination for Hepatitis C.

Please Note #1: The Orphan Druganaut Blog has decided to include a Post on the three-drug regimen for hepatitis C even though it isn’t an orphan drug since the Blog has been following the new FDA Breakthrough Therapy designations since the beginning of 2013.

Please Note #2: FDA Official Logo from FDA website.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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