Fw: NATAP: Telbivudine Recommended for EU Approval by EMEA
- NATAP http://natap.org/
SEBIVO(R) (telbivudine) Recommended for Approval in European Union as a new Treatment for Patients with Chronic Hepatitis B
Fri, 23 Feb 2007
>From Idenix Pharmaceuticals, Inc.PressRelease
CAMBRIDGE, Mass., Feb. 23 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. 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, <1/10) adverse reactions in telbivudine-treated patients reported by week 52 in the GLOBE study were dizziness, headache, cough, diarrhea, nausea, abdominal pain, skin rash, fatigue and blood testing showing higher levels of liver enzymes, amylase, lipase or creatine kinase. Uncommon (greater than or equal to 1/1,000, <1/100) adverse reactions included joint pain, persistent muscle weakness or muscle pain and malaise.
Idenix is co-promoting the product as TYZEKA(R) (telbivudine) in the United States, and as SEBIVO(R) (telbivudine) in France, Germany, Italy, Spain and the United Kingdom in collaboration with Novartis Pharma AG under a development and commercialization agreement established in May 2003.
Important Information About Telbivudine
The following information about telbivudine is adapted from the U.S. Food and Drug Administration's approved product label. It is anticipated that similar language related to the product's indication and important safety information will pertain for the product once approved by the European Commission.
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. This indication is based on virologic, serologic, biochemical and histologic responses after one year of treatment in nucleoside-treatment-naive adult patients with HBeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease.
Important Safety Information -- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. -- Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including telbivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted. -- Cases of myopathy have been reported with telbivudine use several weeks to months after starting therapy. Myopathy has also been reported with some other drugs in this class. Physicians considering concomitant treatment with these or other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor and advise patients to report any signs or symptoms of unexplained muscle pain, tenderness or weakness, particularly during periods of upward dosage titration. Telbivudine therapy should be interrupted if myopathy is suspected, and discontinued if myopathy is diagnosed. -- Because telbivudine is eliminated primarily by renal excretion, co- administration of telbivudine with drugs that affect renal function may alter plasma concentrations of telbivudine and/or the co-administered drug. Dose interval adjustment is recommended in patients with creatinine clearance < 50mL/min including those with ESRD on hemodialysis. For patients on hemodialyis, telbivudine should be administered after hemodialysis. -- The safety and efficacy of telbivudine in liver transplant recipients are unknown. If telbivudine treatment is determined to be necessary for a liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, such as cyclosporine or tacrolimus, renal function should be monitored both before and during treatment with telbivudine. -- Patients should be advised that treatment with telbivudine has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination. -- Safety and effectiveness of telbivudine in pediatric patients under the age of 16 years have not been established. -- Creatine kinase (CK) elevations were more frequent among subjects on telbivudine treatment. Grade 3/4 CK elevations occurred in 9% of telbivudine-treated patients and 3% of lamivudine-treated patients. -- The optimal duration of treatment with telbivudine has not been established. The relationship of initial treatment response to outcomes such as hepatocellular carcinoma and decompensated cirrhosis are unknown. About Hepatitis B
Chronic hepatitis B is a significant public health issue in Europe. Caused by the hepatitis B virus (HBV), which attacks liver cells, chronic hepatitis B can lead to liver scarring (cirrhosis), liver cancer and liver failure.(1) In Europe, there are an estimated one million new HBV infections every year,(2), with an incidence ranging from 29 cases for every 100,000 people in western Europe to 523 per 100,000 in eastern Europe.(2) Of these, 90,000 will become chronic carriers and 24,000 will die from cirrhosis or liver cancer.(2)
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