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Roche's ribavirin Copegus available in all EU Countries within months
  Right now there is one FDA approved ribavirin available in your pharmacy. In October FDA approval is expected for Roche's Pegasys (pegylated interferon) for use as monotherapy. FDa approval for the combination of Pegasys with ribavirin is expected in december. So Roche is manufacturing its own ribavirin which they have been using in their clinical studies. This ribavirin is expected to be on the market and available in your pharmacy.
This is an announcement from Roche. Roche's ribavirin Copegus available in all EU Countries within months Hepatitis C drug completes Mutual Recognition Procedure in the European Union.
Roche announced today that it had received confirmation that the Mutual Recognition Procedure has been completed for its proprietary ribavirin, Copegus. This important milestone means that all EU member states have agreed to approve Copegus for the treatment of chronic hepatitis C in combination with interferon alfa-2a (Roferon A) or peginterferon alfa-2a (40 KD) (Pegasys).
"Today's approval of our stand-alone application means that we have satisfied all European Union member states of the safety and efficacy of the Copegus/ Pegasys combination treatment in patients infected with the hepatitis C virus ," said William M. Burns, head of the pharmaceutical division at Roche, adding that "this paves the way for the commercial availability of Copegus in all EU countries within one to three months. This is very important news as combination therapies are now standard for the treatment of hepatitis C."
The Dutch Medicines Evaluation Board, as the EU Reference Member State, first approved Copegus on April 9th which started this two-step approval process. National approvals will follow swiftly as Copegus is now an approved drug. Copegus is manufactured by Roche as a light pink, oval shaped, film-coated tablet containing 200 mg of ribavirin.
Copegus is indicated for the treatment of adult patients with chronic hepatitis C who have not previously been treated, including patients with fibrosis or compensated cirrhosis. It is also indicated for the treatment of adult patients who have responded to interferon alpha monotherapy but have since relapsed. Copegus is always prescribed as a combination regimen with interferon alfa-2a (Roferon A) or peginterferon alfa-2a (40 KD) (Pegasys).
About Pegasys
Pegasys, a new generation hepatitis C therapy that is different by design, provides significant benefit over conventional interferon therapy in patients infected with HCV of all genotypes. The benefits of Pegasys are derived from its new generation large 40 kilodalton branched-chain polyethylene glycol (PEG) construction, which allows for true seven-day viral suppression and is preferentially distributed to the liver, the primary site of infection. Pegasys is administered once weekly in an easy-to-use pre-filled syringe with a fixed 180 mcg starting dose for all patient types.
Pegasys has now been approved in 47 countries, including the European Union. In the EU, it is indicated for the treatment of histologically proven chronic hepatitis C in adult patients, including patients with early stage cirrhosis. It is approved both as a combination therapy with ribavirin and as monotherapy. In the United States, Pegasys in combination with Copegus was granted a priority review by the FDA and its approval is anticipated later this year.
About Hepatitis C
Hepatitis C is a serious blood-born viral infection that attacks the liver, and in many patients it leads to liver disease, cirrhosis and cancer. It is the leading cause of liver transplantation. Only identified in 1989, the HCV virus has infected more than 170 million people world-wide, making it more common than the HIV virus.
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