Regulatory Focus™ > News Articles > Warfarin Patients Stand to Benefit from New FDA-Approved Drug Kcentra, Company Says

Warfarin Patients Stand to Benefit from New FDA-Approved Drug Kcentra, Company Says

Posted 30 April 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has approved Kcentra (prothrombin complex concentrate), a new biological treatment indicated for the urgent reversal of vitamin K antagonist (VKA), a class of anticoagulants that can lead to major bleeding events and death.

Prior to Kcentra's 29 April 2013 approval by FDA's Center for Biologics Evaluation and Research (CBER), the only FDA-approved method to reverse VKA was through an infusion of blood plasma, regulators said.

The therapy could have the most potential for patients now taking blood thinners like warfarin, FDA explained. "Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding."

Numerous Advantages, but New Risks

The drug also has an advantage relative to plasma in that it does not require a patient's blood type to be known prior to administration, and does not need to be kept in a frozen state, eliminating the need for thawing. In addition, "Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation," Karen Midthun, director of CBER, said in a statement.

The drug is not without its risks. FDA said Kcentra will come with a boxed warning regarding the risk of blood clots and advising patients to be monitored for symptoms of thromboembolic events.

The drug's manufacturer, CSL Behring, mirrored FDA's assessment, adding that the principal benefit will be for patients taking warfarin who experience acute major bleeding.

"FDA approval of Kcentra is an important advancement in warfarin reversal, as it provides medical professionals with a new tool that can efficiently stop major bleeding in patients for whom plasma may not be optimal," said Lynne Powell, senior vice president of commercial operations at CSL Behring.

The company cited figures saying that of the three to four million patients on warfarin, an estimated 29,000 experience warfarin-associated bleeding each year.

FDA Approval Notice for Kcentra

CSL Behring Statement on Kcentra

Tags: approval

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