Admin_Adham
A new generic oral anticoagulant in orodispersible film formulation has won regulatory support in Europe, potentially broadening access and ease of use for patients requiring anticoagulation across multiple indications.
In its September meeting, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use issued a favorable recommendation for Rivaroxaban Koanaa (Koanaa Healthcare Spain), a generic version of Xarelto, which has been authorized in the EU since 2008. The therapy is intended for the prevention of venous thromboembolism (VTE), treatment and prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE), prevention of stroke and systemic embolism in adults with nonvalvular atrial fibrillation and risk factors, and for the treatment and prevention of VTE in children and adolescents.
It will be available as 10 mg, 15 mg, and 20 mg orodispersible films, broadening administration options for patients with difficulty swallowing tablets.
Rivaroxaban works as a selective, direct factor Xa inhibitor within the antithrombotic drug class. This mechanism blocks factor Xa activity, disrupting both intrinsic and extrinsic coagulation pathways. The inhibition prevents thrombin generation and clot formation.
Indications by Strength
- 10 mg: Prevention of VTE in adults undergoing elective hip or knee replacement surgery
- 15 mg:
- Adults: Prevention of stroke and systemic embolism in nonvalvular atrial fibrillation with risk factors such as heart failure, hypertension, diabetes, age ≥ 75 years, or prior stroke/transient ischemic attack
- Adults: Treatment and prevention of recurrent DVT and PE
- Children or adolescents < 18 years weighing 30-50 kg: Treatment and prevention of VTE after at least 5 days of parenteral anticoagulation
- 20 mg:
- Same adult indications as 15 mg: Nonvalvular atrial fibrillation and DVT/PE
- Children or adolescents < 18 years weighing > 50 kg: Treatment and prevention of VTE after at least 5 days of parenteral anticoagulation
Complete usage recommendations will appear in the summary of product characteristics, published on the EMA website in all official European Union languages once the European Commission grants marketing authorization.
