Immunex Plans To File With The FDA Seeking An Expanded Label For ENBREL To Slow Structural Joint Damage In Patients And to Improve The Signs And Symptoms Of Patients With Early, Active RA
SEATTLE - In patients with early, active rheumatoid arthritis (RA), the primary endpoints from a Phase III study showed that ENBREL® (etanercept) slowed the progression of the disease and reduced the signs and symptoms. ENBREL was found to be generally well tolerated in this clinical trial. This announcement was made today by Immunex Corporation (NASDAQ: IMNX) and Wyeth Ayerst, a division of American Home Products Corporation (NYSE: AHP), the two companies that are co-marketing ENBREL in North America.
Detailed data regarding this clinical trial with a more complete analysis will be presented at a medical meeting in the future. The results described herein are based on investigational data analyzed by Immunex. These data have not been reviewed by the U.S. Food and Drug Administration (FDA) as part of an application for regulatory approval.
"The completion of this major study represents another significant milestone in the development of ENBREL," said Peggy V. Phillips, senior vice president, pharmaceutical development, Immunex. "Based on the positive results of this study, Immunex intends to file a new supplemental biologics license application with the FDA seeking an expanded label for ENBREL to slow structural joint damage in patients with active RA and to improve the signs and symptoms of patients with early, active RA."
The Phase III pivotal study evaluated 633 RA patients with early, active disease who received ENBREL or methotrexate, using two primary endpoints: