HTB

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.

Source:

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).

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