Idenix' Sebivo close to EMEA approval

The USA's Idenix Pharmaceuticals has received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), recommending that the European Medicines Agency (EMEA) grant marketing authorization for Sebivo (telbivudine), its once-daily tablet for adult patients with chronic hepatitis B. The positive opinion from the CHMP follows earlier approvals in the USA, where the drug is already marketed as 600mg tablets, under the brand name Tyzeka, as well as Canada, Switzerland and various other countries in Asia and Latin America.

The CHMP submission was based on data from the pivotal Phase III GLOBE trial, which used a composite primary efficacy endpoint coupling viral suppression with either improved liver disease markers (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg). In HBeAg-positive patients in the GLOBE trial, therapeutic response was 75% (n=345/458) among those on Sebivo and 67% (n=310/463) for those patients treated with lamivudine, while the response for HBeAg-negative patients after one year was 75% (n=167/222) versus 77% (n=173/224), respectively. In the GLOBE study, patients who achieved non-detectable HBV DNA levels at 24 weeks were more likely to undergo e-antigen seroconversion, achieve undetectable levels of HBV DNA, normalize ALT and minimize resistance at one year, the firm noted.