Biotech Values

[DewDiligence]

Re: Phase-3 Pradaxa data in acute VTE

This is the first of two phase-3 Pradaxa trials in the treatment of acute VTE; the other phase-3 trial in this indication is still recruiting and is expected to be completed in mid 2011: http://clinicaltrials.gov/ct2/show/study/NCT00680186 .

For the trial just presented at ASH, the top-line data were reported in August (#msg-43846491). The only problem I can see with the data is a relatively minor one:

Adverse events leading to discontinuation of the study drug occurred in 9.0% of patients assigned to dabigatran and in 6.8% of patients assigned to warfarin (P=0.05).

Pradaxa seems to induce dyspepsia in some patients, which was noted in the phase-3 trial in AF (#msg-41018490). All told, Pradaxa appears to be a major advance relative to warfarin, and I doubt the concern mentioned above will impede the program to a material degree.

Note: Pradaxa is already approved in the EU for VTE prevention (#msg-27956748) and is reimbursed by NICE, which requires a strong benefit-cost tradeoff (#msg-32382343).