A new drug awaits Food and Drug Administration (FDA) approval that could take over the market for Pradaxa. The drug is called Eliquis and it was approved by the European Medicines Agency last month for use in Europe. The next step seeking U.S. FDA approval is a hearing set for March 17, 2013.
All of this is happening as the house of cards is falling for Pradaxa maker, Ingelheim Boehringer. The Judicial Panel on Multidistrict Litigation (JPML) says that Pradaxa lawsuit filings have increased more than 50 percent since September.
What do we know about this alternative drug?
Eliquis, marketed by Pfizer and Bristol-Myers, is expected to grab a share of the market. Eliquis (apixaban) is prescribed to prevent strokes in patients with atrial fibrillation, a heart-rhythm disorder. It had been on the market in Europe to prevent blood clots following hip or knee replacement surgery. The FDA has taken a pass on Eliquis twice, but that is not deterring Big Pharma which stands to make $3 to $5 billion a year on Eliquis as about one in four U.S. adults are at risk for developing atrial fibrillation.
A study published in the New England Journal of Medicine on Eliquis as a treatment for venous thromboembolism (blood clots) showed it effective as a long-term therapy. The drug works by inhibiting a blood clotting protein, Factor Xa, which blocks blood clot formation.
The companies involved will continue to push for approval to prevent stroke and systemic embolism in patients with atrial fibrillation.
The problem with Pradaxa has been uncontrolled bleeding that has killed more than 500 patients in the two years the drug has been on the market. So how does Eliquis fare by comparison? Researchers found rates of major bleeding with Eliquis were less than 1 percent. Major bleeding was associated with the higher dose of Eliquis, however, just like Pradaxa, there is no standard antidote to reverse the thinned blood after trauma to the body. The companies are seeking an antidote and report one showed efficacy in a rat model.
Is that good enough to enter the marketplace?
While health experts continue to debate blood thinners a good rule of thumb is to never be the first to try a new drug. Not until it has been on the market for at least a couple of years do we know whether it will be good for the patient or just good for the bottom line of the drug companies involved.