On Friday, June 7, the maker of the experimental drug sofosbuvir announced that the drug had been given priority review status by the FDA. The FDA grants this status to drug candidates that may offer major advances in treatment over existing options.
In clinical studies, some people have been treated with sofosbuvir and ribavirin only which still resulted in high cure rates. In this case, using sofosbuvir without Peg-interferon as part of the treatment regimen will help reduce the types of serious side effect many people have to manage throughout treatment. Also, other people, with harder-to-treat genotypes, have seen cure rates in the 90% range … a higher rate of cure compared to current standard-of-care.
The target review date for sofosbuvir is December 8, 2013.