Positive CHMP opinion for anticoagulant edoxaban in management of atrial fibrillation and venous thromboembolism


News - Apr. 30, 2015

During the April 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, edoxaban received a positive opinion from the Committee for the prevention of stroke and systemic embolism in atrial fibrillation (AF), and the prevention and treatment of venous thromboembolism. This positive opinion recommends the granting of a marketing authorisation for this factor Xa inhibitor.

The antithrombotic agent edoxaban is a highly selective, direct and reversible inhibitor of factor Xa. Inhibition of factor Xa in the coagulation cascade reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation.

The CMPH states the benefits of edoxaban as its ability to:
  • reduce the combined risk of stroke and systemic embolic events in patients with nonvalvular AF who are at risk of stroke and systemic embolic events.
  • treat and reduce the risk of recurrence of symptomatic venous thromboembolism in patients who had acute symptomatic deep vein thrombosis and/or pulmonary embolism.
The most common side effects are cutaneous soft tissue haemorrhage (up to 5.9%), epistaxis (up to 4.7%) and vaginal haemorrhage. Bleeding can occur at any site and may be severe and even fatal. Other common adverse reactions for edoxaban were anaemia, rash and abnormal liver function tests.

The full indication is: “Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
 News Release EMA April 24 2015

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