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Grifols registers positive topline outcomes from phase 3 fibrinogen clinical tr

Grifols, a leading producer of plasma-derived medicines, announced positive results from Biotest's phase 3 trial of fibrinogen concentrate (FC), BT524, for acquired fibrinogen deficiency (AFD). FC met its primary endpoint, matching standard care in reducing intraoperative blood loss in AFD patients while maintaining safety.

This trial marks progress towards a potential therapy for severe blood loss during major surgery. AFD, often treated with cryoprecipitate or fresh frozen plasma, lacks precision and requires extensive preparation. FC offers immediate, precise treatment, potentially revolutionizing care.

Expected for regulatory approval in Q4 2024, BT524 could be the first US-approved FC for AFD, tapping into an $800 million market. Grifols' expertise in managing surgical bleeding, coupled with Biotest's innovations like Yimmugo and trimodulin, strengthens its position in plasma therapies.

The AdFIrst trial confirms FC's efficacy in major surgeries, offering tailored, effective therapy compared to alternatives. Grifols-Biotest synergy promises continued advancements in plasma medicine.