FDA rejects licence extension for Xarelto
pharmafile | June 26, 2012 | News story | Sales and Marketing | ACS, Bayer, FDA, J&J, JJ, Pradaxa, Xarelto
The FDA has set a Complete Response Letter to Bayer and J&J over its blood thinner Xarelto.
The firms, which both own certain rights to the drug, were seeking a new licence for Xarelto to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome (ACS).
But the FDA said that it wants more information from the drug, and sent the firms a Complete Response Letter.
This comes after an FDA panel of medical experts said last month that it couldn’t recommended Xarelto for this new indication, and expressed concern about missing clinical trial data and high bleeding risks.
“We are confident of the safety and efficacy of Xarelto [rivaroxaban] in this indication and will work closely with our development partner Janssen Research & Development, to address the questions set forth by the FDA,” said Dr Kemal Malik, head of global development at Bayer.
Xarelto is already approved for three uses in the US, including: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, and to reduce this risk in people who have just had hip replacement surgery.
It is also licensed to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.
But it does not look like it will be adding a fourth approval to this list, at least until Bayer and J&J submit more data to the FDA.
Xarelto is in competition with two other new oral blood thinners: Pfizer and BMS’ Eliquis and Boehringer’s Pradaxa.
Pradaxa gained US approval in 2010 for use in atrial fibrillation, while Eliquis is still under FDA review – a decision on the drug is expected by the end the week.
But Xarelto’s rivals failed in treating patients with ACS, and an approval for those patients would have given Bayer and J&J a lead on a potentially lucrative new market for these type of medicines.
Ben Adams
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