European regulatory advisors have recommended the approval of Gilead’s chronic hepatitis C (HCV) treatment Harvoni.
Harvoni, which combines Gilead’s blockbuster Sovaldi (sofosbuvir) and ledipasvir, blocks the action of proteins that are essential for HCV to replicate – the protein NS5B for Sovaldi and NS5A for ledipasvir.
New regimens such could allow the cure of patients with chronic HCV without the need for treatments involving interferons, medicines, which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of patients.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed the use of Harvoni, which was evaluated under the Agency’s accelerated assessment programme, putting it on course for European approval before the end of the year.
The decision was based on phase III data evaluating 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.
The trials, which included cirrhotic and non-cirrhotic patients who were new to HCV treatment, showed high efficacy against genotypes 1, 3 and 4, including patients post-transplant. The most common side effects are fatigue and headache.
HCV affects between 0.4% and 3.5% of the population of EU member states, some nine million people, and is the most common single cause of liver transplantations in the EU.
Over the past few months, the CHMP has recommended marketing authorisations for three other medicines for the treatment of HCV – Sovaldi, J&J’s Olysio and BMS’ Daklinza.