CPMP Recommends Roferon-A Approval

7 November 1994

The European Union Committee for Proprietary Medicinal Products has recommended the approval of Hoffmann-La Roche's Roferon-A (interferon alfa-2a) for the treatment of chronic hepatitis C.

In Phase III trials in more than 1,800 patients, the company reported that up to 89% of patients respond to treatment. Response occurs within three months, and a permanent and sustained response, once treatment has been discontinued, can be expected in up to 44% of patients.

The product was first launched in 1986 and is now approved in more than 70 countries for the treatment of different cancers as well as for chronic hepatitis B. In France, Italy and Japan the product is already available for the treatment of chronic hepatitis C.

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