GrifolsGrifols eyes US, EU filings for fibrinogen replacement therapy
14 Feb 2024
Clinical ResultPhase 3
GrifolsGrifols announced data from a Phase III study showing that its blood-clotting treatment was as effective as standard therapy at managing severe blood loss in patients during surgery. The company plans to submit its fibrinogen concentrate, called BT524, for approval in both the US and Europe in the fourth quarter.
Acquired fibrinogen deficiency (AFD) usually occurs during surgical procedures when there is an insufficient amount of the glycoprotein complex fibrinogen to stop bleeding. In the AdFIrst study, patients who had high blood loss during planned spinal or abdominal surgery were randomised to treatment with BT524 or with standard treatment using cryoprecipitate or fresh frozen plasma.
However, the drawback with standard treatment is that plasma also contains other proteins and elements that aren't necessary, so large volumes are needed to ensure enough fibrinogen. By contrast, GrifolsGrifols said its concentrate allows "patients on the operating table [to] immediately receive only what's essential to curtail haemorrhaging."
The AdFIrst trial met its primary endpoint, demonstrating that BT524 was non-inferior to standard care at reducing intraoperative blood loss, with patients given the fibrinogen concentrate experiencing 291mL less blood loss versus the comparator group. Detailed results will be presented later this year.
Meanwhile, Grifols recently hired new CEO Nacho Abia and said two founding family members would leave their executive posts at the company, following a damaging short seller report that questioned the Spanish drugmaker's debt ratio. Grifols has pledged to take legal action in an effort to recoup losses caused by the Gotham City Research report, which led to the company's shares plunging as much as 43% when it was released last month.
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