Warnings Coming for Novartis Hepatitis B Treatment

The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use recommends that new warnings be included in the product information for Sebivo, a treatment for chronic hepatitis B.

The warning advises doctors to watch Sebivo (telbivudine)-treated patients for signs of diabetic neuropathy. In a trial investigating the combination therapy of telbivudine 600-mg daily with pegylated interferon alfa-2a 180-mcg once weekly, an increased risk of peripheral neuropathy was observed, according to the EMEA.

Sebivo, which is called Tyzeka in the U.S., is co-promoted by Novartis and Idenix. It was approved by the European Commission last April based on data from the GLOBE study, which demonstrated the benefits of Sebivo over lamivudine in achieving rapid suppression of the hepatitis B virus.