Regulatory Affairs

Gilead obtains FDA priority review status for Sofosbuvir NDA

PBR Staff Writer Published 10 June 2013

Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV).

The investigational product is an oral nucleotide analogue inhibitor to be administered once each day with the safety and efficacy profile yet to be evaluated.

Under the Prescription Drug User Fee Act (PDUFA), FDA has set a target review date of 8 December 2013, following the filing of the NDA by the company.

The use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection is supported by the data submitted in the filing.

Additionally, the use of sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection is also supported.