EMA Validates Gilead's LDV-SOF Combination For HCV Genotype 1

Gilead Sciences Inc. announced that the European Medicines Agency has validated the company’s Marketing Authorization Application (MAA) for the once-daily fixed-dose combination of ledipasvir (LDV) 90 mg and sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. The EMA has also accepted Gilead’s request for accelerated assessment of LDV/SOF.

The company submitted data from three Phase III studies to support the MAA for NS5A inhibitor LDV90 mg and the nucleotide analog polymerase inhibitor (SOF) 400 mg for the treatment of adult patients with genotype 1 HCV infection for eight or 12 weeks, depending on previous treatment history and whether or not the patients have cirrhosis.

The company stated in its press release, “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.”

Genotype 1 is the most common form of HCV in Europe and is responsible for 60 percent of infections around the world. Standard treatments such as pegylated interferon and ribavirin (RBV) may not be suitable for some patients.

Norbert Bischofberger, PhD, EVP of Research and Development and CSO of Gilead Sciences, said, “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. 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 company said the accelerated assessment could shorten the EMA review period by about two months but does not guarantee approval from the agency or a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). Gilead said that if LDV/SOF is approved, it could be available for marketing in the EU by the end of 2014.