Institute of Good Manufacturing Practices India®

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Grifols documents positive topline outcomes from the phase 3 fibrinogen clinical trial

Grifols, a global leader in plasma-derived medicines, celebrates Biotest's phase 3 trial success with BT524, a fibrinogen concentrate (FC) for acquired fibrinogen deficiency (AFD). The trial confirms BT524's efficacy in reducing intraoperative blood loss, matching standard care but with improved precision and safety. AFD, often complicating surgeries due to insufficient fibrinogen, traditionally relies on cryoprecipitate or fresh frozen plasma, both less precise and requiring thawing. BT524's tailored approach offers immediate, precise treatment, potentially revolutionizing AFD care.

Expected for regulatory review in late 2024, BT524 targets a lucrative global market, projected at USD 800 million. Grifols' expertise in managing surgical bleeding, including fibrinogen-based products, underscores BT524's significance. The success further aligns with Grifols' strategy of innovation and diversification, bolstered by Biotest's acquisition, enhancing plasma access and product portfolio.

Innovations like Yimmugo and trimodulin from Biotest complement BT524's advancement, marking significant strides in addressing critical medical needs.