EMA validates Gilead’s marketing application for sofosbuvir for the treatment of hepatitis C

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection, which was submitted to the European Medicines Agency (EMA) on April 17, 2013, has been fully validated and is now under assessment. The data submitted in this MAA 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.

Chronic HCV is a major cause of liver cancer and liver transplantation in Europe and around the world. The current standard of care for HCV involves 24-48 weeks of therapy with RBV and peg-IFN, which has to be injected and is associated with significant side effects.

“The clinical and economic burden of untreated HCV is substantial and growing rapidly. An estimated five million Europeans are living with hepatitis C, the majority of whom have not yet been diagnosed or are not in care. In addition, many are not suited to receive the current treatment regimens,” said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. “If approved, sofosbuvir has the potential to improve cure rates, while reducing the duration of HCV therapy and reducing or eliminating the need for interferon injections.”

The MAA for sofosbuvir is supported primarily by data from four Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, 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 (HCV undetectable) 12 weeks after completing therapy (SVR12).

Review of the MAA will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states of the European Union (EU). EMA has accepted Gilead’s request for accelerated assessment for sofosbuvir, a designation that is granted to new medicines of major public health interest. Although accelerated assessment could shorten EMA’s review time of sofosbuvir by approximately two months, it does not guarantee a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, sofosbuvir could be available for marketing in the EU in the first half of 2014. Gilead submitted a U.S. regulatory application for sofosbuvir in April 2013.

Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.