Gilead Gets FDA Priority Review of Hepatitis C Combo Drug Decision on combination of Sovaldi with velpatasvir expected in June By TESS STYNES

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.

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The combination of sofosbuvir plus velpatasvir works against genotypes 1 through 6.  For a breakdown of cure rates click here....

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