FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) said Tuesday that its Marketing Authorisation Application for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus infection, which was submitted to the European Medicines Agency on April 17, has been fully validated and is now under assessment.
The data submitted in the Marketing Authorisation Application support the use of sofosbuvir and ribavirin as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with ribavirin and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV infection.
The Marketing Authorisation Application for sofosbuvir is supported mainly by data from four Phase 3 studies, in which 12 or 16 weeks of sofosbuvir-based therapy was found to be superior or non-inferior to currently available treatment options or historical controls, based on the proportion of patients who had a sustained virologic response 12 weeks after completing therapy.
Review of the Marketing Authorisation Application will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union.
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.
If approved, sofosbuvir could be available for marketing in the EU in the first half of 2014, the company asid.
Gilead submitted a U.S. regulatory application for sofosbuvir last month.
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