Merck’s HCV Combo Will Test FDA’s ‘Breakthrough’ Rescission Process
This article was originally published in The Pink Sheet Daily
Agency cites availability of other recently approved therapies in notifying Merck of intent to rescind the designation for grazoprevir/elbasvir in hepatitis C. Sponsor will seek a meeting with FDA to make its case for retaining breakthrough status.
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US FDA cited strong efficacy, good safety of Gilead's Harvoni and AbbVie's Viekira Pak in rescinding breakthrough therapy designation for the sofosbuvir/velpatasvir fixed-dose combination in hepatitis C patients with genotype 1 infection.
FDA told Merck it planned to rescind a ‘breakthrough’ designation for grazoprevir/elbasvir in genotype 1 HCV, but now has designated the combo in genotype 4 and in genotype 1 patients with end-stage renal disease.
Recent approvals of hepatitis C treatments Sovaldi, Harvoni and Viekira Pak lead agency to reconsider ‘breakthrough’-worthiness of Bristol’s daclatasvir and Merck’s doublet therapy. FDA’s willingness to rescind shows the risk sponsors face in trying to retain the designation as other competitors reach market.