Grifols wins pediatric label expansion for THROMBATE III from FDA

Spanish plasma-based medicines producer Grifols (MCE: GRF) today announced that the US Food and Drug Administration (FDA) has approved an expanded indication for THROMBATE III, the company’s antithrombin III [human concentrate], to include pediatric patients diagnosed with hereditary antithrombin deficiency (hATd).

With this expansion, THROMBATE III becomes the first and only antithrombin concentrate (ATc) approved for adults and pediatrics with hATd, a frequently undiagnosed blood clotting disorder that may affect up to 700,000 people in the USA. People with this condition have a higher-than-average risk of developing abnormal blood clots.

According to Grifols, considering that hATd has one of the highest thrombotic risks of all of the inherited thrombophilias and 85% of patients with hATd will have at least one thrombotic episode by age 502, this approval represents a significant step forward for patients and families impacted by hATd.