Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, including colonoscopies. Data for the therapy suggests that the drug produces a slow onset of sedation, helping avoid potentially dangerous cases of sudden general anesthesia, which can trigger breathing difficulties.
The sedative is for patients with a minimum to moderate need of sedation. And the experts said that the drug could help fill a gap in hospitals and clinics that may be shorthanded in people trained in general anesthetics. Panel members asked Eisai, which acquired the drug with its buyout of MGI Pharma, for more studies on the sedative's impact on the elderly and obese.
- see Eisai's release [1]
- read the report [2] in the Wall Street Journal
Related Articles:
FDA staffers say that Eisai sedative appears safe [3]
Eisai expands U.S. ops with $3.9B MGI buyout [4]
Links:
[1] http://www.fiercebiotech.com/press-releases/fda-advisory-committee-votes-favor-approval-fospropofol-disodium-injection-sedation-0
[2] http://online.wsj.com/article/SB121019516752974835.html?mod=googlenews_wsj
[3] http://www.fiercebiotech.com/story/fda-staffers-say-that-eisai-sedative-appears-safe/2008-05-05?utm_medium=rss&utm_source=biotech_FDA&cmp-id=OTC-RSS-FB0
[4] http://www.fiercebiotech.com/story/eisai-expands-u-s-ops-3-9b-mgi-buyout/2007-12-10