Wednesday, October 15, 2008

Kogenate FS approved for Daily prophylaxis

The FDA has approved a "new use" for Kogenate FS.

FDA quote:
"Administering Kogenate FS to children with hemophilia A on a daily basis before a bleeding event occurs will reduce bleeding into joints and help prevent joint damage, a major cause of disability in hemophiliacs," said Dr. Jesse Goodman, director of the agency's Center for Biologics Evaluation and Research. (italics mine)

Nice bit of marketing juice for Bayer's Kogenate FS. But perhaps an underlying benefit is to signal an acknowledgement for insurers that a robust prophylactic regime should be fully embraced and properly covered.


Rixblix said...

Daily? Are folks infusing it that often? (Aside from IT). I think the prophy thing also helps prevent insurers from denying product because most product aren't approved for prophy.

Patrick Brogan said...

Yea, Daily? I thought that was a bit extreme. But I suppose if it greases the skids for better coverage then what the hey.