Replies to post #151755 on Biotech Values

[genisi]

the FDA analysis of the Pradaxa data indicates with some moderately high confidence that the increased bleeding that happens with Pradaxa as patients get older is largely independent of renal function.

Still, the label was revised earlier this year to include the need to assess and monitor renal function and lower dose if required.

http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf

[DewDiligence]

…if Eliquis avoids the age problem (which I think it does) and is enough better than warfarin overall (which I also think it is - if memory is not flawed) then Eliquis may be a slam dunk despite being irreversible at this point in time.

In addition to all that, Eliquis will be heavily promoted by the saleforces of two Big Pharma (PFE and BMY). I’m on record with a prediction that Eliquis will, in due course, become the biggest-selling drug of all time in peak annual sales.

[genisi]

the data (perhaps it exists and I missed it) comparing patients with a high ability to control INR vs Eliquis

Only data I see on this is: "Patients in the warfarin group had an INR in the therapeutic range (2.0 to 3.0) for a median of 66.0% of the time and a mean of 62.2% of the time, after the exclusion of INR values during the first 7 days after randomization and during study-drug interruptions." I'm sure that for patients with better controlled INR levels, outcomes improves. Perhaps this is the group that will be last to switch from warfarin.

the data about benefit and risks vs warfarin after start up.

All I see on this point is that: "Investigators at all study centers were encouraged to enroll a sizable proportion of patients (=40%) who had not previously received warfarin. Approximately 57% of the patients had previously received a vitamin K antagonist" but also: "The results were consistent in subgroups according to geographic region, status with respect to previous warfarin exposure, age, sex, level of renal impairment, and risk factors for stroke, as well as in other predefined subgroups."

http://www.nejm.org/doi/full/10.1056/NEJMoa1107039#t=articleTop