FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) announced that the Committee for Medicinal Products for Human Use or CHMP, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application or MAA for Harvoni,an investigational once-daily tablet combining the NS5A inhibitor ledipasvir or LDV 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir or SOF 400 mg, for the treatment of chronic hepatitis C virus or HCV infection in adults.
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union.
The CHMP positive opinion for Harvoniis supported by data from three Phase 3 studies (ION-1, ION-2 and ION-3). These studies evaluated 8, 12 or 24 weeks of treatment withHarvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.
The positive opinion was also supported by preliminary data from the SOLAR-1 trial in decompensated cirrhotic and pre- and post-transplant patients, the ELECTRON-2 trial in genotype 3 patientsand phase 2 studies in genotype 4 patients.
Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi. Sovaldi is also approved for use in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.
Harvoniis an investigational product and its safety and efficacy have not been established in the European Union.
Copyright RTT News/dpa-AFX