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
"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).
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
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.