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FDA Recommends Limited Use of Anticoagulant Drug Edoxaban

The FDA has recommended limited use of the drug Edoxaban produced by the Japanese pharmaceutical company Daiichi Sankyo Co. Edoxaban is a daily anticoagulant that inhibits Factor Xa, a protein that plays a major role in blood clotting.

About the FDA’s Decision

Following revision by the U.S. Food and Drug Administration, patients taking Edoxaban for atrial fibrillation are advised to limit their dosage to 60 mg, although it would be ideal to limit the drug to only those patients with abnormal kidney function

The 60 mg dose of Edoxaban outperformed its counterpart warfarin (a widely used anticoagulant) in the treatment of mildly renally impaired patients but was significantly worse than warfarin in its treatment with individuals with normal renal function.

Reviewers said: “Although the … overall findings support effectiveness, efficacy outcomes by baseline renal function have potential implications for approval or labeling.”

Effectiveness of Edoxaban in Treatment

A late-stage clinical trial of Edoxaban released last year demonstrated that it was safe and more effective than warfarin in preventing strokes and blood clots, and was associated with much less major bleeding (this is the biggest risk with blood thinners).

Warfarin has been marketed for over 50 years and is effective in preventing strokes but needs a supplemental use of blood level monitoring, dosage adjustments, and dietary restrictions.

Reuters says: “Savaysa, which is the proposed brand name for edoxaban in the United States, is also undergoing regulatory review for the treatment of venous thromboembolism (VTE).”

If approved, Edoxaban would compete with the following brands in its relative market:

  • Xarelto (sold by Bayer AG and Johnson and Johnson)
  • Eliquis (sold by Bristol-Myers Squibb Co and Pfizer Inc.)
  • Pradaxa (made by privately held Boehringer Ingelheim)

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