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FDA Breakthrough Therapy Designation: Merck Receives #25

October 23, 2013

Merck announces on October 22, that the FDA grants MK-5172/MK-8742 oral combination regimen the coveted Breakthrough Therapy Designation (BTD) for the treatment of chronic Hepatitis C (HCV). The combination regimen consists of:

•   Investigational HCV NS3/4A protease inhibitor, MK-5172

•   Investigational HCV NS5A replication complex inhibitor, MK-8742.

At the 64th American Association for the Study of Liver Diseases (AASLD) Annual Meeting, November 1 – 5, in Washington D.C., interim data from an ongoing Phase IIB clinical trial of MK-5172/MK-8742 in HCV Genotype 1 is to be presented.

Some Observations

•   This is the 2nd BTD for Merck :

Row Num

Drug Name

Sponsor                Company Indication

7

Lambrolizumab Merck Melanoma

25

MK-5172/MK-8742 Merck Hepatitis   C

•   4 BTDs are for Hepatitis C, the most for any one indication :

Row Num

Drug Name

Sponsor                Company Indication

11

3-drug regimen Bristol-Myers Squibb               (BMS) Hepatitis C

12

3-drug combination AbbVie Hepatitis C

19

Sofosbuvir             +Ledipasvir             Gilead             Sciences Hepatitis C

25

MK-5172/MK-8742 Merck Hepatitis C

Please Note: “A group of three balloons on ribbons” JPEG by AJ (Open clip Art Library image’s page) [see page for license] | Wikimedia Commons.

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

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