Provided by FierceBiotech
October 25, 2013 | By John Carroll
There were no big surprises for Gilead's $11 billion hepatitis C drug sofosbuvir at today's FDA panel review. The therapy, which promises to help create an entirely new standard of care for the millions of people afflicted with the virus, won a clear endorsement from agency experts. And now it's likely headed for a near-term approval as the FDA formally considers the application.
The panel voted unanimously that the drug and various combinations should be approved for all four basic genotypes. Sofosbuvir was endorsed in combination with ribavirin for genotypes 2 and 3, and in genotypes 1 and 4 in combination with ribavirin as well as in combination with interferon for treatment-naive patients.
The agency already signaled its views in an internal review released earlier this week which heralded the therapy as the first interferon-free drug that clearly demonstrated its efficacy and safety among important groups of hep C patients.