4-Nov-14 10:30 AM  CST

New Hope for the Prevention of Stroke and Embolism on the Horizon

It seems there may be new hope on the horizon in fight for the prevention of stroke and embolism. On Thursday, the FDA panel voted 9 to1 to recommend approval of the new oral anticoagulant drug Edoxaban (savaysa). Edoxaban (savaysa), which is manufactured by the Tokyo based pharmaceutical company, Daiichi Sankyo, is the 4th oral anticoagulant up for approval by the FDA in recent years.

            Edoxaban (savaysa) is approved for the proven of stroke and embolism risk that is often associated with atrial fibrillation (AF). The drug, which has a dosing regimen of once daily, has a better bleeding profile than other anticoagulants such as Coumadin (warfarin). The reduced risk of bleed is of course a positive for the drug, but not all the news is good. Edoxaban (savaysa) has come under question for its affect upon renal function.

            Edoxaban (savaysa) seems to have a higher risk of renal impairment when compared to other anticoagulant drugs like Coumadin (warfarin). This result was concluded in patients with varying degrees of renal impairment, from no renal impairment to mild and high levels of impairment. Still some feel the risk of impairment out weights the risk of excessive bleeding and monitoring that come with Coumadin (warfarin) therapy.

The biggest controversy with Edoxaban (savaysa) is whether or not the FDA will approve the use of both 60mg and 30mg Edoxaban (savaysa). Given the increased renal risk some FDA panel members felt more studies were needed before a 60mg tablet should be made available on the US market. Edoxaban (savaysa), which is already available in European and Asian markets, may be available in the US later in 2015. Representatives from Daiichi Sankyo stated they would continue to work with the FDA in order to reach complete approval in the US.

 

References:

Daiichi Sankyo, News Release for Endoxaban (savaysa), 10/31/2014, http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006206.html, referenced 31. October 2014

O’Riordan, M. “FDA Panel Votes 9 to 1 in Favor of Endoxaban for Stroke Prevention in AF Patients,” Medscape, 10/31/14, http://www.medscape.com/viewarticle/834164, referenced, 31. October 2014

Phend, C. “FDA Approves Savaysa as Fourth NAOC” Medpage Today, 10/30/2014, http://www.medpagetoday.com/Cardiology/Arrhythmias/48331, referenced 31.October, 2014Exo


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Source: Sandy Andrews  

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