First recommendation for HCV drug vaniprevir, in Japan.
By Michael Haydock, Lead Analyst
25 September 2014
I am the Lead Analyst of the immunology and inflammation and infectious diseases and vaccines teams at Datamonitor Healt...
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Japan has recommended Merck & Co’s vaniprevir for approval in HCV. This is the first such regulatory decision worldwide for this drug. This coincides with Datamonitor Healthcare’s estimation that the drug would be launched in Q1 of 2015. Vaniprevir was filed for approval in Japan last December and was granted a priority review. It is indicated for the treatment of untreated, interferon-unresponsive, or relapsed genotype 1 chronic hepatitis C patients.
Datamonitor Healthcare analyst, Michael Haydock, evaluated vaniprevir in his pipeline report (click here to view) and forecast the drug as having the lowest commercial potential of the marketed and pipeline protease inhibitors, largely due to the drug being limited to Japan. Not only that but Merck & Co has not incorporated vaniprevir into an interferon-free regimen, rendering the drug unable to compete with recently approved and late-phase therapies that dispose of the need for interferon and ribavirin..
Vaniprevir will face competition from other new releases in 2015 such as Sovaldi, Sunvepra and Daklinza. Sunvepra and Daklinza, both developed by Bristol-Myers Squibb, were recently launched as the first interferon- and ribavirin-free combination in Japan and are expected to be adopted as the gold standard for GT-1b patients; the same patient population vaniprevir is indicated for.
Posted in Infectious Diseases.