The European Medicines Agency has recommended marketing
approval for Merck’s hepatitis C protease inhibitor boceprevir (Victrelis), the agency announced on May
Boceprevir is the first direct-acting antiviral agent for
hepatitis C to be approved in Europe. It has
been approved for use by patients with hepatitits C genotype 1 and compensated
liver disease in combination with the current standard treatment of pegylated
interferon and ribavirin.
It has been approved for use by previously untreated
patients and by patients who have failed previous therapy.
When added to standard therapy boceprevir significantly
increased the cure rate in all groups of patients, with the best results seen
in patients new to treatment.
Common side-effects of boceprevir treatment include anaemia, fatigue, nausea and headache.
Boceprevir is manufactured by Merck.
In the United States Merck has agreed a marketing tie-up
with Roche, the manufacturer of the Pegasys
formulation of pegylated interferon. Roche has agreed to promote boceprevir as
part of a package of hepatitis C treatment using its well-established sales
Merck is also able to draw on the sales network inherited
from Schering-Plough, which merged with the company in 2009. Schering Plough
brought its own version of pegylated interferon, Intron A, to the partnership, but there have been some suggestions
that boceprevir has performed better when dosed with the Pegasys formulation of pegylated interferon.
Boceprevir was approved by the United States Food and Drug
Administration on May 13th.