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Committee for Medicinal Products for Human Use Summary of Opinion for Baraclude (entecavir) for HBV treatment
  From the News Archive - Apr. 28, 2006
International Nonproprietary Name (INN): entecavir
LONDON, April 27, 2006- On 27 April 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Baraclude filmcoated tablets (0.5 mg and 1 mg) and oral solution (0.05 mg/ml) intended for treatment of chronic hepatitis B virus (HBV) infection in adults. The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
The active substance of Baraclude is entecavir, an antiviral substance which belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors (J05F10). Entecavir interferes with the ability of the hepatitis B virus to replicate itself by inhibiting DNA synthesis in HBV infected cells. The benefits with Baraclude relate to its ability to slow the progression of chronic hepatitis B infection, a serious disease that attacks the liver. This was shown in three clinical studies in patients naive to previous antiviral treatment and in patients with resistance to lamivudine, another antihepatitis B agent, infected by wild type virus (HBeAg positive), pre-core mutant virus (HBeAg negative) and with compensated liver disease. After 48 weeks of treatment (or 2 years for those who haven't responded), Baraclude achieved responses higher or similar to lamivudine, with regard to improvement in the liver inflammation and degree of liver fibrosis (scarring) caused by HBV, improvement, reduction in the amount of virus in blood, normalisation of the liver function and seroconversion. The optimal duration of treatment with Baraclude is unknown.
The most common side effects are headache, fatigue, dizziness and nausea. Spontaneous exacerbation of hepatitis B after discontinuation of antiviral therapy, including Baraclude, has also been reported and therefore patients need to be closely monitored upon treatment cessation.
The approved indication is: "for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. This indication is based on clinical trial data in patients with HBeAg positive and HBeAg negative HBV infection, nucleoside naive patients and patients with lamivudine-refractory hepatitis B." It is proposed that entecavir therapy should be initiated by a physician experienced in the management of chronic hepatitis B. Detailed conditions 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 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 that there is a favourable benefit to risk balance for Baraclude and therefore recommends the granting of the marketing authorisation.
* Summaries of opinion are published without prejudice to the Commission Decision, which will normally be issued within 67 days from adoption of the Opinion. ** Applicants may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.
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