ELIQUIS (apixaban) - Venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.

The clinical benefit of ELIQUIS (apixaban) is substantial in the new MA indication “Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age”.

Considering:

• the efficacy data for apixaban in the paediatric population, primarily derived from a clinical study, the interpretation of which can only be descriptive insofar as no statistical hypothesis was formulated, suggesting an efficacy similar to that of standard heparin and/or VKA anticoagulant therapy in the treatment of venous thromboembolism and the prevention of VTE recurrence,
• the safety data from this study, that do not enable a higher risk of minor bleeding than with standard heparin and/or VKA anticoagulant therapy to be excluded,
• the level of evidence of these results, which remains limited,
• the safety profile that is similar overall to that in the adult population,
• the absence of comparative data versus XARELTO (rivaroxaban), the first DOAC made available in France in this indication (direct comparison not expected given their concomitant development),
• uncertainties with respect to its efficacy, safety and longer term use in routine practice, particularly in the youngest children, of whom there were few in the pivotal study,

the Committee deems that ELIQUIS (apixaban) provides no clinical added value (CAV V) in the management of venous thromboembolism in the paediatric population after at least 5 days of initial parenteral anticoagulant therapy.