November 11, 2014

Merck & Co. to submit grazoprevir, elbasvir hepatitis C combination to FDA in 2015

(Ref: Merck & Co., The Lancet, StreetInsider, NASDAQ)

November 11th, 2014
By: Joe Barber

Merck & Co. said Tuesday that it plans to submit a marketing application for its investigational combination regimen of grazoprevir and elbasvir to the FDA in 2015 for the treatment of chronic hepatitis C. The company also reported results from the Phase II C-WORTHy trial, showing that the treatment combination, either with or without ribavirin, was associated with sustained virologic response rates at 12 weeks of 90 percent or greater in both treatment-naïve and -experienced patients. Eliav Barr, vice president of infectious diseases at Merck Research Laboratories, commented "we are encouraged by the findings for grazoprevir/elbasvir in the C-WORTHy trial and look forward to advancing our broad Phase III programme."


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