Regulatory briefs: Gilead files sofosbuvir; FDA approves Diclegis; Health Canada clears Dysport

9 April 2013

US biotech firm Gilead Sciences (Nasdaq: GILD) says it has submitted a New Drug Application to the US Food and Drug Administration for approval of sofosbuvir, its once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.

The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.

Gilead plans to file for regulatory approval of sofosbuvir in other geographies, including the European Union, in the second quarter of 2013. The European Medicines Agency has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest.

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