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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 of other recently approved treatments” for HCV genotype 1 patients...

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