Gilead Sciences, Inc. (NASDAQ:GILD) has announced that Sovaldi, its blockbuster drug used in the treatment of hepatitis C virus, has received the approval of the CFDA – China Food and Drug Administration. The treatment received approval for use in adolescents aged between 12 and 18 as well as in adults. This is in patients suffering from the HCV genotype 1-6.
“The approval of sofosbuvir (Sovaldi) in China provides more treatment options for Chinese HCV patients. The clinical trials in China and around the world provide evidence that the treatment is effective for multiple genotypes,” said Sovaldi’s Phase III study principal investigator, Prof. Lai Wei.
Chinese market
In the world’s most populous country hepatitis C virus is number four with regards to the most commonly occurring infectious diseases and affects around 10 million Chinese. The approval for the drug thus presents a big market opportunity for Gilead Sciences.
In the United States Sovaldi received the approval of the Food and Drug Administration four years ago. Solvadi was approved for use in Europe in 2014 and is currently permitted in a total of 79 countries.
Besides Sovaldi single-tablet regimens developed by Gilead Sciences for use in the treatment of hepatitis C virus, Epclusa and Harvoni, are also undergoing trials in China. Gilead’s portfolio of hepatitis C virus drugs got a boost when Epclusa was approved last year in June in the United States and a month later in the European Union. Also aiding in the boosting of the portfolio was the approval of Vosevi by the U.S. Food and Drug Administration.
Competition and pricing pressures
The hepatitis C virus drug franchise of Gilead Sciences is however facing competitive threats and pricing pressures especially from rival drug maker, AbbVie Inc (NYSE:ABBV), which has developed Viekira XR and Viekira Pak. Another threat is being posed by Merck & Co., Inc. (NYSE:MRK) after it launched MRK Zepatier.
To diversify its portfolio Gilead Sciences has announced plans of becoming a dominant player in cell therapy, an emerging field, by acquiring cell therapy pioneer Kite Pharma. Gilead did not give a specific date when this will be concluded.
On Thursday shares of Gilead Sciences Inc fell by 3.52% to close the day at $80.91.