Gilead Sciences, Inc. (NASDAQ:GILD) has announced that it has received the green sign from China Food and Drug Administration (CFDA) for the use of Sovaldi (Sofosbuvir) to treat chronic hepatitis C virus infection.
The company made the announcement yesterday, revealing that it has received the CFDA approval to address chronic hepatitis C virus infection using Sovaldi (Sofosbuvir). The latter is an oral nucleotide analog polymerase inhibitor designed to address the health condition through single daily doses. The Chinese regulatory body approved the use of the drug to treat adults as well as teenagers from 12 to 18 years old.
Gilead received approval for the hepatitis C treatment based on phase 3 clinical trials that the company carried out specifically for the Chinese market. The results of the phase 3 trials revealed that Sovaldi could be used to 92 percent to 100 percent of patients with genotype 1, 2, 3 or 6. The clinical trial evaluated the performance of Sovaldi combined with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) in different patient populations.
The company also revealed that the safety profiles of the regimens in the phase 3 clinical study demonstrated consistency especially with the side effects of ribavirin and interferon. Pyrexia and hematological abnormalities are the most common side effects.
“The approval of sofosbuvir 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, which offers HCV patients in China a better chance at curing their disease,” stated Professor Lai Wei, the former Chairman of the Chinese Society of Hepatology of the Chinese Medical Association and Sovaldi’s phase 3 principal investigator.
The approval of Sovaldi is quite a significant step for Gilead as well as for hepatitis C patients in the country. Hepatitis B is one of the most prevalent illnesses in China with the number of infected individuals approaching 100 million. The Chinese government is also taking steps to address the emerging concerns about hepatitis C. Some of these steps include speeding up the approval process as well as prioritizing potential treatments.
Gilead Sciences stock closed the latest trading session on Tuesday at $83.76.
