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Grifols Aims For Largely Untapped Market With Successful Fibrinogen Deficiency Study

 
• By Alaric DeArment

The Phase III trial of BT524 produced positive topline results in patients with acquired fibrinogen deficiency, potentially making it the first fibrinogen concentrate to win US FDA approval for that indication.

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Grifols, S.A.’s acquisition of Biotest AG a little more than two years ago looks set to pay off handsomely as one of the drugs that Biotest developed, BT524, produced positive topline Phase III study results in patients with acquired fibrinogen deficiency (AFD).

The Spanish health care company and Biotest, based in Germany, said 14 February that AdFirst, the Phase III study of BT524 in AFD, met its primary endpoint of showing noninferiority compared with standard of care in reducing intraoperative blood loss in AFD patients undergoing planned major spinal or abdominal surgery

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