FDA Approves Eliquis, Blood Thinners Pradaxa, Xarelto Have New Competitor
The Food and Drug Administration has just cleared the twice delayed approval of the drug Eliquis, a blood thinner prescribed to help patients diagnosed with non-valvular atrial fibrillation or the most common type of heart rhythm abnormality.
The drug, developed by Bristol-Myers Squibb and Pfizer, will be the newest addition to a group of three next-generation blood thinner drugs approved by the FDA in the last two years, including Pradaxa and Xarelto.
Over a year late, the drug was first approved in Japan and the European Union. With the initial approval date set for March 2012, the next scheduled ruling date was set for March 17, 2013, according to reports, but was bumped up.
By June 2012, the FDA had to unfortunately postpon the drug's approval after waiting for results from ARISTOTLE, a clinical study comparing the safety and effectiveness of Eliquis to the drug warfarin, a more dated anticoagulant, testing it in more than 18,000 patients with non-valvular atrial fibrillation.
Side effects for the drug, as with most blood thinners, can include unexpected or prolonged bleeding in some patients. However, doctors have several ways to help and correct excessive bleeding events for patients taking this and other drugs, but there is currently no known antidote for Eliquis, Pradaxa or Xarelto. Doctors are currently working to stop life-threatening bleeding events for those on Eliquis.
Financial analysts from Credit Suisse in New York project have also reported that Eliquis could achieve $5.2 billion in sales by 2020, but the frequency of bleeding complications will determine the drug's future.