Replies to post #167613 on Biotech Values

[oc631]

For whatever reason, the design of TURQUOISE-1 was released within the last week. Far behind TURQUOISE-2.

[jq1234]

FDA Released Draft Guidance on DAA for HCV

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf

Main points/changes:

SVR12 as primary endpoint rather than SVR24;

Recommend NDA contain data from patients co-infected with HIV as well as patients with decompensated cirrhosis and pre- and post-liver transplant patients.

The later point is consistent with ABBV/ENTA TURQUOISE-1 and 2 trial design:

We recommend that a sponsor submitting an original NDA for a DAA, as part of an IFN containing or IFN-free regimen, include data on HIV/HCV co-infected subjects.
......
We strongly suggest that an original NDA submission for the treatment of HCV with a combination of DAAs contain some clinical data from subjects with decompensated cirrhosis, as well as pre- and post-transplant subjects.