Merck Revives ‘Breakthrough’ Status For HCV Combo
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
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.
Omaveloxolone, Reata Pharmaceuticals’s orphan drug for treating patients with Friedreich’s ataxia, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.