More than two years after it had originally planned, Eisai has filed for FDA approval of the experimental breast cancer drug eribulin, marking the first new drug application filed by Eisai in the U.S. in a decade. In a rare triple shot, Eisai filed its marketing application simultaneously in Japan and Europe in hot pursuit of blockbuster income.
Eisai had hoped to follow Bristol-Myers Squibb's path to the FDA and file for an accelerated approval back at the end of 2007, but the agency insisted on a late-stage clinical trial. That study enrolled 762 women and demonstrated an improvement in overall survival in eribulin-treated patients compared with a treatment of the "physician's choice."
The Japanese pharma company has high hopes for this therapy. It's already projected revenue of more than $1 billion a year after it reaches its peak. The therapy has been on an extended journey of discovery. Eribulin depends on an active ingredient first discovered in a marine sponge back in 1992.
- here's the Eisai release
- and here's the story from Bloomberg