Boston, MA 09/29/2014 (wallstreetpr) – Biopharmaceutical company, Gilead Sciences, Inc. (NASDAQ:GILD), disclosed that the European medicines agency, Committee for Medicinal Products for Human Use or CHMP, has taken a favorable view on its Market Authorization Application or MAA for its investigational once-daily tablet, Harvoni. The drug is meant for treating the adults infected by chronic hepatitis c infection.
Accelerated Review Process
According to Gilead Sciences, Inc. (NASDAQ:GILD)’s statement, the opinion of CHMP was adopted after an accelerated process of review that is especially reserved for medicinal products of major interest to public health. As a result of the recommendation, European Commission would review the CHMP’s recommendation. The European commission would be the final authority to approve drugs in the 28 nations of the European Union.
Gilead said that it has provided supporting data of stage 3 clinical trials to CHMP. These trials determined treatment of 8, 12 or 24 weeks with Harvoni and without or with ribavirin, among the 2,000 genotype1 HC patients, who had liver disease. The trial also included both cirrhotic, as well as, non-cirrhotic patients who were fresh to the treatment of HCV and those who had failed treatment before with an interferon-based regimen, which included HCV protease inhibitor contained regiments.
This apart, the favorable opinion was also fuelled by preliminary data from its pre- and post-transplant and decompensated cirrhotic patients, the ELECTRON-2 study in genotype three patients and stage two trials in genotype four patients.
Gilead Sciences, Inc. (NASDAQ:GILD) said that about nine million people were affected in Europe by the hepatitis C virus, which was the main root for liver transplantation and liver cancer. The most prevalent form of HCV in Europe was Genotype 1 and significantly it represents 60% of infections globally. Genotypes two and three followed it for the most prevalent form. However, in Asia and Africa, genotypes 4 – 6 were more prevalent.
Harvoni is an investigational drug, and its efficacy and safety were not established in the European Union. The company indicated that its another drug, Sofosbuvir, was granted authorization for marketing in the European Union earlier in January current year.