Biotech Values

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FDA Released Draft Guidance on DAA for HCV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.