EMA validates Gilead’s marketing application for Ledipasvir/Sofosbuvir fixed-dose combination tablet for Genotype 1 Chronic Hepatitis C infection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection, has been fully validated and is now under assessment by the European Medicines Agency (EMA). The data included in the application, which was submitted on February 27, 2014, support the use of LDV/SOF among adult patients with genotype 1 HCV infection for eight or 12 weeks, depending on prior treatment history and whether they have cirrhosis.

Genotype 1 is the most prevalent form of HCV in Europe, and accounts for 60 percent of infections worldwide. Current treatments for genotype 1 HCV include pegylated interferon and ribavirin (RBV), which may not be suitable for certain patients.

“Based on the results of the Phase 3 ION studies, LDV/SOF has the potential to transform HCV therapy for genotype 1 patients by eliminating the need for interferon injections and ribavirin and reducing the duration of treatment,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “If approved, LDV/SOF would be the first all-oral treatment option that has the potential to cure HCV in as little as eight weeks.”

The MAA for LDV/SOF is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 genotype 1 HCV patients were randomized to receive the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks. Trial participants included patients who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and patients with compensated cirrhosis.

Review of the MAA will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 28 member states of the European Union. The EMA has accepted Gilead’s request for accelerated assessment of LDV/SOF, a designation that is granted to new medicines of major public health interest.

LDV/SOF is an investigational product and its safety and efficacy has not yet been established. Although accelerated assessment of this investigational fixed-dose combination could shorten EMA’s review time 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, LDV/SOF could be available for marketing in the EU by the end of 2014. Gilead has also submitted regulatory applications for LDV/SOF in the United States and Canada.

SOF as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the tradename Sovaldi®, and is available in the United Kingdom, Ireland, Germany, France, Austria, Sweden and Finland. Sovaldi is also approved in the United States, Canada, New Zealand and Switzerland.