The footnote at the very bottom of #msg- said: “Xarelto is not included in the table above because it is not yet approved.” Actually, it would be more accurate to say that MNTA did not include Xarelto (a/k/a/ rivaroxaban) in the table of M118 comparator drugs because, to date, there are no phase-3 data for Xarelto in the ACS indication. Rather, Xarelto’s approval in the EU and its pending NDA in the US are for VTE prevention.
Xarelto does have phase-2 data in ACS, as described in a Nov 2008 PR from JNJ (#msg-33517140):
In phase-3, the doses being tested are 2.5mg and 5mg (BID) (http://clinicaltrials.gov/ct2/show/NCT00809965 ). In other words, the lowest dose being tested in phase-3 is half the lowest dose that was tested in phase-2 due to the bleeding risk.
All told, I think it’s fair to say that Xarelto has its work cut out for it in the ACS indication.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.