Gilead Sciences Inc. (GILD: Quote) on Monday said it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration or FDA, seeking approval of sofosbuvir, a oral nucleotide analogue for the treatment of chronic hepatitis C virus infection.
The company in a statement added that the data submitted in the NDA supported the use of sofosbuvir and ribavirin, as an oral therapy for patients with genotype 2, 3 HCV infection.
Further, Gilead said that it planned to file for regulatory approval of the drug in the European Union, in the second quarter of 2013.
John Martin, Chairman and Chief Executive of Gilead Sciences, stated, "Sofosbuvir's antiviral potency, safety profile and once-daily administration have the potential to improve cure rates by simplifying and shortening therapy for patients with this disease."
by RTT Staff Writer
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