Bayer Submitted Application to EMA to Extend Xarelto Marketing Authorization

| By | Bayer, EMA, Xarelto

Bayer has submitted an application to the European Medicines Agency (EMA) to extend the Xarelto marketing authorization, making it available for children up to 17 years old with confirmed VTE, including cerebral vein and sinus thrombosis. The application is for the treatment of VTE and prevention of VTE recurrence and builds on the positive results from the phase III EINSTEIN-Jr. study.

This is the largest pediatric study ever conducted for the treatment of VTE and demonstrated a lower occurrence of VTE in children treated with rivaroxaban compared with standard of care (injections of heparin alone or in combination with a vitamin K antagonist such as warfarin). In the EINSTEIN-Jr. study children received rivaroxaban as tablets or as a newly-developed suspension for oral use.

Bayer will apply for a patent extension of six months once the review of the pediatric procedure is completed by EMA and the EU Product Information has been updated. The extension would extend the patent period of Xarelto in Europe to April 2024.

“This application represents an important step towards bringing a new treatment option to children with VTE and at risk of recurrent VTE for whom there are currently limited options,”

said Dr. Joerg Moeller, Member of the Executive Committee at Bayer AG’s Pharmaceuticals Division and Head of Research and Development.

“We look forward to working with the European Medicines Agency to make this treatment available to patients as quickly as possible.”

Children with life-threatening illnesses are now living longer healthier lives thanks to advances in medicine, but these children who are often hospitalized for extended periods of time have a higher risk of VTE. Current pediatric treatment of VTE is surrounded by uncertainty as it is largely based on observational data and extrapolation from adult VTE studies. Moreover, the availability of a treatment option that does not require prolonged subcutaneous or intravenous injections and regular monitoring is currently lacking. Injections over an extended period are a huge burden especially for babies and small children. A treatment option such as an oral liquid formulation that does not require injections and regular monitoring will be an important asset in pediatric practice.

VTE includes cerebral vein and sinus thrombosis, a blood clot in the brain, pulmonary embolism (PE), a blood clot that travels to the lung, and deep vein thrombosis (DVT), a blood clot in a deep vein. VTE is an increasingly common complication among hospitalized children with the most common risk factor for VTE being venous catheterization. Currently recommended treatment options for VTE include unfractionated heparin, low molecular weight heparin, and fondaparinux with or without a vitamin K antagonist therapy. No non-vitamin K oral anticoagulant is currently approved for use in this setting.

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