18 November 2025 - FDA approval was based on submitted data extrapolation from two clinical trials in adult patients addressing critical gaps in the clinical comprehension and treatment of paediatric hereditary antithrombin deficiency.

Grifols today announced that the US FDA has approved an expanded indication for Thrombate III, the company’s antithrombin III [human concentrate], to include paediatric patients diagnosed with hereditary antithrombin deficiency.

Read Grifols press release