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Merck Revives ‘Breakthrough’ Status For HCV Combo

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.

Merck & Co. Inc. is back in the “breakthrough” therapy designation game, as FDA has deemed its Phase III combo grazoprevir/elbasvir as offering sufficient therapeutic advancement in hepatitis C patients with genotype 4 infection and in genotype 1 patients with end-stage renal disease who are on hemodialysis.

That suggests that the expedited regulatory pathway is still viable for certain HCV populations. FDA had indicated that the “availability...

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