The European Medicines Agency has recommended marketing approval for Merck’s hepatitis C protease inhibitor boceprevir (Victrelis), the agency announced on May 20th.
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 network.
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.