Topline results reported from phase III trial of fibrinogen concentrate BT 524 as a treatment for acquired fibrinogen deficiency
Grifols, one of the world’s leading producers of plasma-derived medicines, announced that Biotest’s positive topline results from AdFIrst, its phase III clinical trial of its fibrinogen concentrate (FC), BT 524, advance this potential treatment for acquired fibrinogen deficiency (AFD), an underserved growth market
The FC from Biotest, a Grifols Group company, met the primary endpoint. It is as effective as standard of care in reducing intraoperative blood loss in patients with AFD, while also maintaining an excellent safety profile.
Current treatments are cryoprecipitate (a plasma extract) or fresh frozen plasma, which also contain other proteins and elements that are not necessary, so large volumes are needed to ensure enough fibrinogen. Plus both need to be thawed in advance, time consuming when lives are at risk. Fibrinogen concentrate, which is also used to treat AFD, is a precision medicine in which patients on the operating table immediately receive only what’s essential to curtail hemorrhaging.
BT 524 will likely enter regulatory authorization processes in Q4 2024 starting in Europe and the United States. It would be the first FC approved for an AFD indication in the U.S. in a global market with an estimated potential of $ 800 million.
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