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Pfizer-Bristol Myers' Eliquis Flops In Post-Heart Surgery Trial

Pfizer-Bristol Myers' Eliquis Flops In Post-Heart Surgery Trial
  • Pfizer Inc (NYSE: PFE) and Bristol Myers Squibb Co (NYSE: BMY) partnered Eliquis (apixaban) failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR), according to the data from a new trial called Atlantis presented at the virtual American College of Cardiology meeting.
  • The drug was linked to an “unexplained signal” in a subset of populations with a higher rate of non-cardiovascular deaths which did not need blood thinners apart from the surgery.
  • Eliquis did show some numerical benefit in preventing the formation of blood clots around the site of the TAVR without an increased risk of bleeding but couldn’t hit its outcomes marks.
  • “Our results do not suggest we can routinely use (Eliquis) as the default antithrombotic treatment after successful TAVR,” said lead author Jean-Philippe Collet in a statement. “Although the safety of (Eliquis) is the same as standard care and it better prevents valve thrombosis, we observed an unexplained signal on non-cardiovascular mortality among patients who do not need oral anticoagulation.”
  • In patients prone to excess bleeding on vitamin K agonists like Eliquis, researchers said the drug could emerge as the treatment of choice post-TAVR. Either way, the unexplained deaths are worthy of further analysis, they said. Researchers also posited the results could be a “play of chance,” Collet said.
  • One year after the surgery, the study found no significant difference in the primary endpoint, a composite of all-cause death, stroke, heart attack, valve thrombosis, pulmonary or systemic embolism, deep vein thrombosis major bleeding between Eliquis and SOC. 
  • About 18% of patients on Eliquis posted one of those events compared with 20.1% on SOC standard care. There were also numerically higher numbers of secondary endpoints, including death, stroke, heart attack, or systemic embolism, in the Eliquis group compared with the control.
  • Price Action: PFE shares are down 0.12% at $39.97, and BMY shares are down 0.34% at $64.66 during the premarket session on the last check Monday.

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Posted-In: BriefsBiotech News Health Care FDA General

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