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Bristol-Meyers Squibb Receives FDA Breakthrough Therapy Designation

April 29, 2013

Bristol-Myers Squibb (BMS) during their first quarter 2013 financial results meeting on April 25, 2013, announces that the FDA has given the Breakthrough Therapy Designation for an experimental, non-orphan three-drug regimen for hepatitis C. The triple Direct-Acting Antiviral (DAA) combo includes :

• Daclatisvir, an NS5A replication complex inhibitor
• Asunaprevir, an NS3 protease inhibitor
• BMS-791325, an NS5B non-nucleoside polymerase inhibitor.

At last week’s European Association for the Study of the Liver (EASL) in Amsterdam, BMS announces new Phase II data demonstrating that both the 12-week and 24-week triple DAA treatment show “high rates of Sustained Virologic Response (SVR) of up to 94% in treatment naïve, genotype 1 chronic Hepatitis C patients at time points ranging from 4 to 36 weeks post-treatment.”

The Breakthrough Therapy Designations granted for drugs that have been identified by the sponsor companies (as of 04/29/13) 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.

The FDA doesn’t disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designations. Per the FDA website, “Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).”

Please Note #1: The Orphan Druganaut Blog has decided to include a Post on 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 designation from 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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