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DewDiligence

07/24/15 2:17 PM

#193705 RE: DewDiligence #193693

ABBV’s PR on FDA approval of Technivie for HCV GT4:

http://finance.yahoo.com/news/technivie-ombitasvir-paritaprevir-ritonavir-tablets-180000731.html

This is the first FDA approval of any all-oral HCV regimen for GT4.

DewDiligence

03/01/17 12:06 PM

#209519 RE: DewDiligence #193693

ABBV/ENTA—FDA expands Technivie* label to include GT4 patients with CP-A cirrhosis:

https://content.govdelivery.com/accounts/USFDA/bulletins/18a3b91

From a commercial standpoint, this label expansion won’t move the needle for ABBV/ENTA since GT4 is a small population in the US (about 6% of all HCV patients) and the GT4 CP-A population is even smaller. Please see #msg-115667263 for related info.

*Technivie is the US brand name for the 2-DAA variant of Viekira Pak that omits Dasabuvir (the non-nuke third agent).