The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval and granting of marketing authorization of SEBIVO® (telbivudine).
SEBIVO® (telbivudine) is a once-a-day tablet (taken with or without food) for the treatment of chronic hepatitis B infection in adult patients – a product co-promoted by Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX) with Novartis Pharma AG (NYSE: NVS).
The positive opinion from CHMP follows earlier approvals in the United States, where the drug is being marketed as TYZEKA® (telbivudine) 600 mg tablets; Canada; Switzerland and various other countries in Asia and Latin America.
An application for marketing approval is pending with the Chinese health authority.
Regulatory submissions have been based primarily on one-year data from the GLOBE study, the largest worldwide registration trial including both HBeAg-positive and HBeAg-negative patients with chronic hepatitis B ever conducted.
USFDA-approved Telbivudine is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Chronic hepatitis B is caused by the hepatitis B virus (HBV), which attacks liver cells and can lead to liver scarring (cirrhosis), liver cancer and liver failure.
Find more details from the press release.
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