U.K. approves pediatric oral suspension form of Bayer's Xarelto

The U.K. approved Bayer's granules for oral suspension formulation on the strength of a phase 3 clinical trial.

The U.K. has approved an oral suspension version of Bayer’s anticoagulant Xarelto to treat venous thromboembolism (VTE) in children. Bayer developed the formulation to eliminate the need for kids with VTE to have injections or regular monitoring. 

Xarelto, a factor Xa inhibitor, received a marketing authorization in the EU in 2008. That approval covered an immediate-release film-coated tablet containing 10 mg of the active ingredient, rivaroxaban. However, the approval only covered adults. Anticoagulants continued to typically be given to children parenterally and in dosage forms designed for adults. 

Pharmaceutical manipulation of adult dosage forms is needed to achieve the pediatric dose. Those manipulations may affect stability and bioavailability and raise the risk of dosing errors, creating the need for formulations designed with the needs of children in mind. 

Bayer responded to the unmet need by developing an oral suspension of rivaroxaban designed to have similar pharmacokinetic properties to its older tableted sibling. The goal was to enable precise dosing and easy administration in children from birth through to 18 years of age.

The U.K. approved the granules for oral suspension formulation on the strength of a phase 3 clinical trial that found the risk of VTE recurrence was similar across two cohorts of children treated with either the oral suspension or body-weight-adjusted Xarelto tablets.

The approval only covers the U.K. A European Medicines Agency committee recommended the drug for approval in November. At that time, the U.K. was subject to EU regulations under the terms of the Brexit transition agreement. With the transition period finishing at the end of 2020, companies now need to seek approval separately in the U.K. and EU.

In the EU, Bayer plans to file for a six-month patent extension once the European Commission confirms the approval. The extension will push patent protection on Xarelto out to April 2024.