US priority review for Pegasys combination

Published: 22-Aug-2002
Regulatory


The US Drug Administration (FDA) has granted a six-month Priority Review Status to the Biologics License Application (BLA) and the New Drug Application (NDA) for Roche's combination therapy of Pegasys, peginterferon α-2a (40KD), and Copegus (Roche's own ribavirin) tablets, for the treatment of chronic hepatitis C in patients without cirrhosis and with cirrhosis with compensated liver disease.

Priority designation is only granted to biologics or drug products that address unmet medical needs, offering significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease according to the FDA. Approval action is expected by the end of the year. The FDA is also reviewing Pegasys monotherapy data and the approval process is underway.

In June Pegasys monotherapy and combination therapy was granted marketing authorisation by the European Commission, making it available in all EU countries and paving the way for approvals in Central and Eastern European countries. Pegasys has been approved in 24 other countries since its first approval in Switzerland in August 2001.

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