The European Medicines Agency (EMA) has fully validated Gilead Sciences‘ marketing authorisation application (MAA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400mg to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection.
Submitted in February 2014, the MAA for the fixed-dose combination drug is currently under assessment by the EMA.
The data included in the MAA supports 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.
Gilead executive vice-president of research and development and chief scientific officer Norbert Bischofberger said based on the results of the Phase III 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," Bischofberger said.
The MAA is based on three Phase III trials, ION-1, ION-2 and ION-3, where around 2,000 genotype 1 HCV patients were given the fixed-dose combination, with or without RBV, for treatment durations of eight, 12 or 24 weeks.
The trial included patients who were treatment-naive or who had failed previous treatment, including protease inhibitor-based regimens, and patients with compensated cirrhosis.
MAA review will be carried out under the centralised licensing procedure, which, when finalised, provides one marketing authorisation in all 28 member states of the EU.
EMA accepted the company’s request for accelerated assessment of LDV/SOF, an investigational product whose safety and efficacy has not yet been established.
If approved by EMA, LDV/SOF could be available for marketing in the EU by the end of this year.
The company has also submitted regulatory applications for LDV/SOF in the US and Canada.
In Europe, genotype 1 is the most prevalent form of HCV and accounts for 60% of infections worldwide.
Existing treatments for genotype 1 HCV include pegylated interferon and ribavirin (RBV), which may not be suitable for certain patients.
Image: Electron micrograph of hepatitis C virus purified from cell culture. Photo: courtesy of TimVickers.