EMA Validates Gilead's Marketing Application For LDV/SOF Combination

(RTTNews) - Gilead Sciences, Inc. (GILD) Thursday said its Marketing Authorisation Application for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir 400 mg for the treatment of chronic hepatitis C virus infection, has been fully validated.

"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, EVP Research and Development and Chief Scientific Officer.

The application is now under assessment by the European Medicines Agency. 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.

The application 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.

LDV/SOF is an investigational product and its safety and efficacy has not yet been established. Upon approval, LDV/SOF will 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.