Gilead Sciences Inc. said the U.S. Food and Drug Administration granted a priority review of its experimental hepatitis C combination drug.
The Foster City, Calif., drugmaker filed a new drug application for the treatment–a combination of the biopharmaceutical company’s Sovaldi with velpatasvir–in late October. The FDA is expected to decide whether to approve the combination therapy by June 28.
The FDA also has given the Sovaldi-velpatasir combination treatment breakthrough therapy designation, which is granted to experimental medicines that may offer major advances over existing options.
The combination of sofosbuvir plus velpatasvir works against genotypes 1 through 6. For a breakdown of cure rates click here….Share This Page