Biotech Values

[DewDiligence]

PFE/BMY report phase-3 Eliquis data in treatment of VTE:

http://in.reuters.com/article/2013/06/30/us-pfizer-bristolmyers-eliquis-idINBRE95T04G20130630

For the composite goal of recurrence of VTE and VTE-related death [the primary efficacy endpoint] there were 59 cases for Eliquis, or 2.3 percent, versus 71 cases for warfarin, or 2.7 percent.

For the primary safety goal of the study, there were 15 reports of major bleeding among Eliquis patients, or 0.6 percent, compared with 49 major bleeds among warfarin patients, or 1.8 percent. The 69-percent reduced major bleeding risk was deemed to be highly statistically significant…

[On the secondary safety endpoint], there were 103 reported cases of clinically relevant non-major bleeding with the Pfizer and Bristol drug versus 215 cases in the warfarin group, or a risk reduction of 52 percent.

Actually, the comparator for Eliquis in this study was not warfarin per se, but rather the sequence of Lovenox followed by warfarin, as is common in actual practice. (See trial details at http://www.clinicaltrials.gov/ct2/show/NCT00643201 ).

Thus, Eliquis was non-inferior to the comparator regimen on efficacy and strongly superior to the comparator on the primary and secondary bleeding (safety) endpoints. These data were presented at the ISTH conference going on this weekend.

The results reported above were from the study called AMPLIFY. BMY/PFE previously released stellar data from a related study called AMPLIFY-EXT in secondary VTE prevention (#msg-82279247). The two studies, which were started in 2008 and intended to be considered as a unit (#msg-29928836), had about 8,000 patients between them (5,400 in AMPLIFY and 2,500 in AMPLIFY-EXT).

The combined data from AMPLIFY and AMPLIFY-EXT should make Eliquis a shoo-in for the composite indication of VTE treatment and secondary prevention, IMO. If successful, Eliquis will be the first new oral anticoagulant with such an indication in the US market.