Brief: Grifols Gets FDA Approval For Thrombate III In Pediatric Patients In U.S.

Grifols SA

18/11/2025 09:08

Nov 18 (Reuters) - Grifols SA GRLS.MC:

RECEIVES EXPANDED INDICATION FOR THROMBATE III LABEL IN U.S., STRENGTHENING TREATMENT OPTIONS FOR PEDIATRIC PATIENTS

EXPANDED LABEL FOR THROMBATE III INDICATES IT CAN BE SAFELY AND EFFECTIVELY USED IN PEDIATRIC PATIENTS WITH HATD, A RARE PATIENT POPULATION

FDA APPROVAL WAS BASED ON SUBMITTED DATA EXTRAPOLATION FROM TWO CLINICAL TRIALS IN ADULT PATIENTS ADDRESSING CRITICAL GAPS IN CLINICAL COMPREHENSION AND TREATMENT OF PEDIATRIC HATD

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