SEBIVO(R) (telbivudine) Recommended for Approval in European Union as a new Treatment for Patients with Chronic Hepatitis B
23 February 2007 - 11:45PM
PR Newswire (US)
CAMBRIDGE, Mass., Feb. 23 /PRNewswire-FirstCall/ -- Idenix
Pharmaceuticals, Inc. (NASDAQ:IDIX) today announced the adoption of
a positive opinion by the European Medicines Agency's (EMEA)
Committee for Medicinal Products for Human Use (CHMP), recommending
granting of marketing authorization of SEBIVO(R) (telbivudine), a
once-a-day tablet taken with or without food, for the treatment of
chronic hepatitis B infection in adult patients. The CHMP's
recommendations are advisory but the European Commission has
historically followed them and the company expects a final decision
to be issued within three months. "Chronic hepatitis B is a very
serious disease affecting more than 350 million people worldwide
and a growing public health problem in Europe," said Jean-Pierre
Sommadossi, Idenix's chairman and chief executive officer. "We are
assembling a strong commercial team in Europe and look forward to
working with Novartis to make SEBIVO available to European patients
as soon as possible after it is formally approved." The positive
opinion from CHMP follows earlier approvals in the United States,
where the drug is being marketed as TYZEKA(R) (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.
Data from the pivotal phase III clinical trial, known as the GLOBE
study, compared telbivudine to lamivudine in 1,367 patients. The
primary efficacy endpoint of the GLOBE study was therapeutic
response at one year, a composite endpoint coupling viral
suppression (serum HBV DNA suppression below 100,000 copies/mL)
with either improved liver disease markers (ALT normalization) or
loss of detectable hepatitis B e-antigen (HBeAg). In HBeAg-positive
patients, therapeutic response was 75 percent (n=345/458) among
patients treated with SEBIVO and 67 percent (n=310/463) for those
patients treated with lamivudine, while the response for
HBeAg-negative patients after one year was 75 percent (n=167/222)
vs. 77 percent (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. In clinical studies SEBIVO was generally
well tolerated with most adverse experiences classified as mild or
moderate in severity. Common (greater than or equal to 1/100,
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