FRANKFURT (Reuters) – Bayer will apply for approval to make its blockbuster blood thinner Xarelto available for treating children, the German company said on Monday, after a study showed strong efficacy and safety in children with thromboembolism.
The results of the phase III study were similar to those seen in previous studies with adults, the German company said in a statement.
Bayer added that it would submit an application to the European Medicines Agency for an extension of the Xarelto marketing authorization. It did not give a time frame.
Xarelto is Bayer’s best-selling drug and contributed 3.6 billion euros ($4.04 billion) in revenue to the group’s pharmaceutical business last year.
Bayer jointly developed Xarelto with Johnson & Johnson’s Janssen Pharmaceuticals, which sells the blood clot preventer under a licensing agreement in the United States.
J&J reported 2018 Xarelto sales of $2.47 billion.
(Reporting by Patricia Weiss; Writing by Thomas Seythal; Editing by Michelle Martin)