Date: 2011-07-18
Type of information: Granting of a Market Authorisation in the EU
Product name: Victrelis®
Compound: boceprevir
Therapeutic area:
Action mechanism: Boceprevir is the first of a new class of medicines for the treatment of chronic hepatitis that directly inhibit the replication of the hepatitis-C virus in hepatitis-C-virus-infected host cells.
Company: Merck&Co (USA)
Disease: chronic hepatitis-C genotype-1 infection
Latest news: * On May 20, 2011, the CHMP has adopted a positive opinion recommending the granting of marketing autorisation for Victrelis® (boceprevir), Merck Sharp & Dohme Ltd, intended for the treatment of chronic hepatitis-C genotype-1 infection, in combination with peginterferon alpha and ribavirin, in adult patients with compensated liver disease who are previously untreated or for whom previous therapy has failed. * On May 13, 2011, the FDA approved Victrelis® (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis® is approved for use in combination with peginterferon alfa and ribavirin. The safety and effectiveness of Victrelis® was evaluated in two phase 3 clinical trials with 1,500 adult patients. In both trials, two-thirds of patients receiving Victrelis® in combination with pegylated interferon and ribavirin experienced a significantly increased sustained virologic response, compared to pegylated interferon and ribavirin alone.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-05-13
UE authorization: 2011-07-18
Favourable opinion UE: 2011-05-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
