FDA briefing documents: Sofosbuvir safe, effective
Gilead's sofosbuvir hep. C drug is safe and effective when used in combination with other therapies. That pronouncement, reported by Reuters today, is not likely to shock anyone, although FDA briefing documents posted on the agency's site ahead of an advisory panel meeting Friday may offer some hints at what reviewers will focus on.
As the news service notes, Gilead is seeking approval to market the drug, sans interferon (INF) but with existing treatment ribavirin (RBV), for patients with the genotype 2 and genotype 3 variants of the diasease. Gilead will also seek approval for use of the drug, with RBV and INF, for patients with the more common genotype 1 variant, as well as for 4, 5 and 6.
Sofosbuvir is vying to become the basis for the first approved all-oral drug for hep. C. Analysts have modeled peak worldwide sales of between $4 billion and $7 billion a year. All-oral regimens are also being tested by BMS and AbbVie.