Gilead's Epclusa Approved As First Pan-Genotypic HCV Therapy
This article was originally published in The Pink Sheet Daily
Fixed-dose combo of sofosbuvir and velpatasvir is approved to treat genotypes 1-6 and be the first ribavirin-free regimen for genotypes 2 and 3 of the virus.
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The number of novel drugs approved by FDA in 2016 was down versus prior years, and many of the drugs that did launch are off to a slow start. The expectation is increasingly for drugs to build sales over time.
Sharply declining HCV sales, three upcoming patent expirations and a lack of near-term pipeline prospects other than HIV candidate bictegravir leave the specialty firm needing to spend some of its gigantic cash reserves on assets to revitalize its portfolio and/or stimulate the R&D engine.
Drug Review Profile of the pan-genotypic HCV treatment shows agency staff debating whether fixed-dose combination's strong efficacy in certain genotype 3 patients could be further maximized by adding ribavirin.