Biotech Values

[DewDiligence]

CHMP approves Xarelto for AF/stroke prevention:

http://www.bloomberg.com/news/2011-09-23/bayer-s-xarelto-wins-eu-drug-panel-backing-for-additional-use.html

Once again, Europe and the US seem to be looking at the same data in a different light. The FDA sharply criticized Xarelto for AF at the advisory panel meeting on 9/8/11, but the panel endorsed approval anyhow (#msg-66936474); the PDUFA date is in early November.

Xarelto is already approved in the EU for VTE prevention following hip/knee surgery (#msg-30972846) and is approved in the US for the same indication (#msg-64830766).