Questions & Answers
On 19 May 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Victrelis 200 mg hard capsules intended for the treatment of chronic hepatitis C (CHC). The applicant for this medicinal product is Merck Sharp & Dohme Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The active substance of Victrelis is boceprevir, a direct acting antiviral (ATC Code is not yet assigned). Boceprevir is the first of a new class of medicinal products for the treatment of chronic hepatitis that directly inhibit the replication of the hepatitis C virus in HCV-infected host cells.
The benefit of Victrelis used in combination with ribavirin and peginterferon alfa is its ability to inhibit viral replication in infected host cells which can lead to the eradication of the virus, correlating to a cure of chronic hepatitis C. As compared to the current treatment with peginterferon alfa and ribavirin, the addition of boceprevir will significantly enhance the proportion of patients that could be cured of their hepatitis C. In some patients the gain of boceprevir will also be translated into a shorter treatment duration required for treatment response.
The most frequently reported adverse reactions were fatigue, anaemia, nausea, headache, and dysgeusia. Boceprevir induces an incremental risk of anaemia as compared to the combination of peginterferon alfa and ribavirin.
A pharmacovigilance plan for Victrelis will be implemented as part of the marketing authorisation.
The approved indication is:
“Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy (see sections 4.4 and 5.1).”
It is proposed that treatment with Victrelis should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR), and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit to risk balance for Victrelis and therefore recommends the granting of the marketing authorisation.
|Name||Language||First published||Last updated|
|CHMP summary of positive opinion for Victrelis||(English only)||20/05/2011|
|INN or common name|
|Therapeutic area||Hepatitis C, Chronic|
|Date opinion adopted||19/05/2011|
Merck Sharp & Dohme Ltd.
|Application type||Initial authorisation|