On 22 February 2007 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Sebivo, 600 mg, film-coated tablet intended for treatment of chronic hepatitis B virus (HBV) infection in adult patients.
The applicant for this medicinal product is Novartis Europharm Ltd.
The active substance of Sebivo is telbivudine, an antiviral substance which belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors (J05AF11). Telbivudine interferes with the ability of the hepatitis B virus to replicate itself, by inhibiting viral DNA synthesis in HBV-infected cells.
The benefit of Sebivo was shown in a clinical study in patients na?ve to previous antiviral treatment infected by wild-type virus (HBeAg positive) or pre-core mutant virus (HBeAg negative) and with compensated liver disease. Patients were mainly infected with HBV genotype B and C. The number Caucasian patients treated with telbivudine was limited, as patients were predominantly of Asian origin. After 52 weeks of treatment, Sebivo achieved responses higher or similar to lamivudine, with regard to reduction in the amount of virus in the blood, associated with seroconversion or normalisation of liver function. The optimal duration of treatment with Sebivo is unknown. In addition to commonly reported side effects, including headache, fatigue and dizziness, the safety profile of Sebivo was mainly characterised by an increase in blood creatinine kinase and muscular disorders, requiring a close monitoring of muscle related side effects. Spontaneous exacerbation of hepatitis B after discontinuation of antiviral therapy, including Sebivo, has also been reported and therefore patients need to be closely monitored upon treatment cessation. A pharmacovigilance plan for Sebivo, as for all medicinal products, will be implemented as part of the marketing authorisation.
The approved indication for Sebivo is: “for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. See section 5.1 of the Summary of Product Characteristics for details of the study and specific patient characteristics on which this indication is based”.
It is proposed that Sebivo treatment should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Detailed recommendations for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European U nion 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 that there is a favourable benefit to risk balance for Sebivo and therefore recommends the granting of the marketing authorisation.