Merck is seeking approval from the US Food and Drug Administration (FDA) for its grazoprevir / elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy to treat adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection.
The company has submitted a new drug application (NDA) to the FDA for the drug and is planning to submit additional licence applications in the European Union and other markets by the end of this year.
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Grazoprevir / elbasvir is an investigational and once-daily single tablet regimen that includes grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A replication complex inhibitor).
Under the firm’s broad clinical trials programme, grazoprevir / elbasvir is being studied in multiple HCV genotypes and in patients with difficult-to-treat conditions such as HIV / HCV co-infection, advanced chronic kidney disease, inherited blood disorders, and liver cirrhosis, as well as those on opiate substitution therapy.
Merck Research Laboratories clinical development senior vice-president Dr Roy Baynes said: "Merck’s submission is based on evidence from our wide-ranging clinical programme assessing the efficacy and tolerability profile of grazoprevir/elbasvir in populations with chronic hepatitis C.
"This submission to the US FDA is an important milestone as we seek to provide patients with a new treatment option for this serious infection."
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By GlobalDataThe NDA was submitted based on data from the pivotal C-EDGE clinical trials programme and C-Surfer and C-Salvage trials, which assessed grazoprevir / elbasvir (100mg / 50mg), with or without ribavirin, in patients with chronic hepatitis C infection.
Earlier, the firm received FDA breakthrough therapy designation for grazoprevir/elbasvir to treat patients infected with chronic HCV GT1 with end stage renal disease on haemodialysis, and for patients infected with chronic HCV GT4.
Image: Electron micrograph of hepatitis C virus purified from cell culture. Photo: courtesy of Maria Teresa Catanese, Martina Kopp, Kunihiro Uryu and Charles.
