CPMP RECOMMENDS MARKETING AUTHORIZATION FOR KINERET.
If approved by the European Commission, Kineret(R) would be the first drug to directly and selectively block interleukin-1 (IL-1), a protein present in excess in RA patients that results in inflammation and joint damage. Kineret(R) is the first recombinant form of the naturally occurring interleukin-1 receptor antagonist (IL-1Ra).
The CPMP's recommendation will be forwarded to the European Commission for their final decision and granting of the marketing authorisation, which generally requires three to four months. Once approved by the European Commission, Amgen would obtain a license to market Kineret(R) throughout the European Union. Launch schedules in each European Union country vary according to each nation's pricing and reimbursement procedures.
"Amgen is committed to high quality research and development in the field of RA as a means of developing efficacious and unique therapies which will enhance the quality of life for RA patients. The CPMP's recommendation on Kineret(R) clearly demonstrates that Amgen's commitment has proved beneficial, and represents a significant step towards bringing this important new therapy to patients who are suffering from the debilitating effects of rheumatoid arthritis," said Aart Brouwer, Vice President, Amgen Europe.
The worldwide clinical trial program for Kineret(R) included nearly 3,000 patients and studied a broad range of patients with varying degrees of disease severity. The most frequent treatment-related adverse events reported were mild to moderate injection-site reactions.
"For rheumatoid arthritis patients, maintaining a `normal' lifestyle in terms of functionality and being able to work, are extremely high priorities," said Prof. Barry Bresnihan, Professor of Rheumatology at St. Vincent's University Hospital, Dublin, Ireland. "Kineret(R) may represent a significant new treatment option for patients with rheumatoid arthritis and should reduce the signs and symptoms of their disease."
Rheumatoid arthritis is the most serious and disabling type of arthritis, affecting more than 3 million Europeans.
The positive CPMP opinion follows approval in the United States by the U.S. Food and Drug Administration.
Amgen, Thousand Oaks, Calif.,is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
For more information, call 805/447-3227.
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|Date:||Jan 1, 2002|
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