Monday, July 19, 1999
Amgen Inc. finally may get something out of its $240 million
investment in Synergen Inc. back in 1994.
At a meeting with the FDA to finalize a Phase III protocol for its
IL-1ra to treat rheumatoid arthritis, the agency decided such a study would not be needed,
according to the company. AMGN therefore will file for approval based on Phase II data,
which showed significant improvements in the primary and secondary end points of American
College of Rheumatology (ACR) composite index and rate of joint damage, respectively.