Biotech Values

[DewDiligence]

Musings on Pradaxa/competitive landscape for oral anticoagulants:

The results you posted from the RE-NOVATE-2 study mirror those from the original RE-NOVATE study reported three years ago (#msg-21155926). In both studies, Pradaxa (dabigratran) was found non-inferior (but not superior) to Lovenox in VTE prevention following hip surgery. The main difference between the two studies is that RE-NOVATE-2 tested only the higher of the two doses of Pradaxa (220mg qD) used in RE-NOVATE.

Pradaxa is approved for VTE prevention in the EU (#msg-27956748) and is one of the rare cases where a new drug gets a quick thumbs-up from the UK’s NICE (#msg-32382343). Based on the clinical data from the two RE-NOVATE studies, Pradaxa ought to be shoo-in for FDA approval in VTE prevention.

All told, Pradaxa is shaping up to be the most consequential of the new oral anticoagulants, IMO. Approval in AF/stroke prevention seems all but assured (#msg-41018490, #msg-41014644, #msg-41024424) and the data to date look promising in acute VTE treatment (#msg-44244839). Success in ACS is less certain, however (#msg-25152872).

What is the salient point from all of the above? The answer, IMO, is that thrombin (FIIa) inhibition matters more than most people probably thought. Pradaxa may be the most successful of the crop of new oral anticoagulants for the simple reason that it’s the only one to act on thrombin rather than FXa.