Link Securities | Grifols (GRF) announced that the US Food and Drug Administration (FDA) has approved the expansion of the indication for Thrombate III, the company’s antithrombin III concentrate, to include paediatric patients diagnosed with hereditary antithrombin deficiency (HAD), according to Bolsamanía.
With this expansion, Thrombate III becomes the first and only antithrombin concentrate approved for adults and paediatric patients with HAD, an often underdiagnosed blood clotting disorder that could affect up to 700,000 people in the United States.
People with this condition have a higher-than-average risk of developing abnormal blood clots. This approval represents a significant advance for patients and families affected by this disease, as HAD presents one of the highest thrombotic risks among hereditary thrombophilias. Furthermore, 85% of patients with HAD will experience at least one thrombotic episode before the age of 50.
