EMA fast-track sofosbuvir/ledipasvir FDC for hepatitis C
Gilead press statement
On 27 March 2014, Gilead announced that the European Medicines Agency (EMA) has agreed to an accelerated assessment for a once-daily fixed-dose combination of sofosbuvir plus ledipasvir.
Sofosbuvir is a nucleotide analogue polymerase inhibitor and ledipasvir is an NS5A inhibitor, that together are indicated as a treatment of chronic hepatitis C genotype 1.
The data included in the application, which was submitted on February 27, 2014, supports the use of LDV/SOF among adult patients with genotype 1 HCV infection for eight or 12 weeks, (depending on their prior treatment history and whether they have cirrhosis).
The Marketing Authorisation Application (MAA) is supported by three Phase 3 studies, ION-1, ION-2 and ION-3, in which nearly 2,000 patients were randomised to receive the fixed-dose combination, with or without ribavirin, for treatment durations of 8, 12 or 24 weeks.
Accelerated assessment reduces the review period by approximately two months.
Gilead press statement. European Medicine’s Agency validates Gilead’s marketing application for ledfipasvir/sofosbuvir fixed-dose combinationtablet for genotype 1 chronic hepatitis C infection. (27 March 2014).