EU recommends approval of sofosbuvir for HCV
EMA press statement
On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) recommended approval for sofosbuvir (400 mg film-coated tablets) as a treatment for chronic hepatitis C.
Sofosbuvir is a direct acting antiviral (DAA, ATC code not yet assigned) and is the first NS5B polymerase inhibitor.
Sofosbuvir provides the first interferon-free treatment option for chronic hepatitis C. In patients where interferon is still needed for efficacy, sofosbuvir enables a shortened treatment duration compared to current standard-of-care. Furthermore, when used before liver transplantation, sofosbuvir can prevent graft reinfection with HCV.
The most common side effects were fatigue, headache, nausea and insomnia. The safety profile of sofosbuvir in combination with ribavirin, with or without peginterferon was consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
A pharmacovigilance plan for sofosbuvir will be implemented as part of the marketing authorisation.
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 made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.
Sofosbuvir is manufactured by Gilead Sciences under the trade name Sovaldi.
EMA press statement. European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C. (22 November 2013).