Biotech Values

[DewDiligence]

Re: Updated FDA guidance for HCV NDAs

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.

True; however, TURQUOISE-1 (for HCV/HIV co-infected patients) will not be part of ABBV/ENTA’s initial NDA because it’s expected to finish in Dec 2014 (#msg-92959364).

SVR12 as primary endpoint rather than SVR24.

SVR12 has been the de facto standard for some time, so this is a case of the FDA guidance following practice rather than influencing it.