Therapeutic Breakthrough For Rheumatoid Arthritis Becomes First Biologic Response Modifier Approved To Treat Children And Teen-Agers With JRA
SEATTLE - ENBREL® (etanercept) was approved today by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active polyarticular-course juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate response to one or more disease modifying medicines. Today's announcement was made by Immunex Corporation (NASDAQ: IMNX) and Wyeth-Ayerst Pharmaceuticals, a division of American Home Products Corporation (NYSE: AHP), the companies who market ENBREL in North America.
JRA is an autoimmune system disease that strikes children before age sixteen and can cause painful joint swelling, deformity, stunted growth and increased mortality. According to the Arthritis Foundation, JRA affects approximately 50,000 children in the United States. The disease can impair a child's ability to take part in physical activities, make daily activities such as schoolwork more difficult, and affect a child's physical appearance.
"I never thought my daughter would be able to get out of bed in the morning without experiencing extreme pain, much less attend school with her peers on a daily basis," said Erite Freed, the mother of a 15-year-old girl, Lauren Blumenthal, with JRA who participated in the ENBREL JRA clinical trial. "ENBREL has had a dramatic effect on my daughter's life."
"Children with JRA face the possibility of a lifetime of pain and
disability," said Daniel J. Lovell, M.D., M.P.H., a pediatric rheumatologist at
Children's Hospital Medical Center of Cincinnati and principal investigator of
the clinical study on which the JRA indication was based. "Rheumatologists have
had limited options to treat children with moderate to severe arthritis. The
approval of ENBREL for JRA opens a new era of hope for these children,
teen-agers and the
Contact: Tim Warner