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Higher Dose COPEGUS(R) 400mg Tablets Approved in the Netherlands as First Step to European Availability
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BASEL, Switzerland, April 24 /PRNewswire/ -- press announcement by Roche
- New 400 mg COPEGUS Tablets Offer Simplified Treatment Regimen to Hepatitis C Patients
Roche announced the start of the Mutual Recognition Procedure for a COPEGUS(R) (ribavirin) 400 mg tablet, following approval by the Dutch Medicines Evaluation Board, the EU Reference Member State. The first higher-dose ribavirin formulation to be approved in Europe, COPEGUS 400 mg will make treatment simpler for patients with chronic hepatitis C - reducing the number of pills to be taken each day by up to 50 per cent. Mutual recognition is an important step in approving COPEGUS 400 mg tablets for commercial use across the European Union (EU), and is expected to take 90 days to complete. COPEGUS tablets are used in combination with PEGASYS(R) (peginterferon alfa-2a (40 KD)), the world's leading treatment for chronic hepatitis C.
"This new COPEGUS 400 mg tablet is a reflection of Roche's commitment to providing patients with simple, convenient solutions that help them stay on therapy and achieve the best chance for a cure," said William M. Burns, head of the pharmaceutical division at Roche. "We look forward to a rapid approval of this new tablet across the EU, so patients can take advantage of its benefits as soon as possible."
COPEGUS is manufactured by Roche in easy-to-swallow, film-coated 200 mg and now 400 mg tablets. In combination with PEGASYS (available in a fixed-dose pre-filled syringe), COPEGUS is indicated for the treatment of chronic hepatitis C in the broadest range of patients, including those with cirrhosis (severe scarring of the liver), normal ALT (alanine aminotransferase, an indictor of liver inflammation), and those co-infected with HIV. COPEGUS is taken orally as a daily dose of 800 mg for patients with genotypes 2 and 3, and 1000/1200 mg for those with genotypes 1 and 4 infections.
Efficacy of PEGASYS and COPEGUS Combination Therapy
PEGASYS and COPEGUS is the only pegylated interferon combination therapy to have demonstrated significantly superior benefits over conventional interferon combination therapy across all HCV genotypes, irrespective of viral load. The combination of PEGASYS and COPEGUS consistently show high cure rates - up to 66 per cent overall sustained virological response - across a wide range of large, randomised clinical studies.[1]
In numerous clinical trials, PEGASYS and COPEGUS have consistently shown high overall sustained virological response rates (indicative of a cure for people with HCV), including in patients with difficult-to-treat disease such as genotype 1 HCV, cirrhosis, and HIV-HCV co-infection.
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. Hepatitis C chronically infects 170 million people worldwide, with an additional three to four million people newly infected each year. It is a leading cause of cirrhosis, liver cancer and liver failure.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation, and a market leader in virology. In 2005, sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Notes to the Editor:
- The Dutch Medicines Evaluation Board approved COPEGUS in combination with PEGASYS on April 9, 2002
- EU approval of COPEGUS in combination with PEGASYS on September 18, 2002
- US FDA approval of COPEGUS in combination with PEGASYS in December 2002
References
[1] Fried, Hadziyannis, Berg, Sanchez-Tapias, Zeuzem.DITTO.
Distributed by PR Newswire on behalf of Roche Pharmaceuticals
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