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Grifols Grifols gears up for FDA approval of fibrinogen replacement therapy

2024-02-14

临床3期临床结果高管变更快速通道

Grifols plans to file for regulatory approval for the AdFIrst (BT524) in both Europe and the US in Q4 of this year. Image Credit: Kittyfly / Shutterstock.

Grifols Grifols pharmaceutical company Grifols has reported positive Phase III trial data for its fibrinogen concentrate, AdFIrst (BT524) as a treatment for reducing blood loss in patients with acquired fibrinogen deficiency (AFD).

The company plans to seek regulGrifols Grifolspproval for the therapy in both Europe and the US in Q4 of this year.BT524 acquired fibrinogen deficiency (AFD)

The active control Phase III trial (2017-001163-20) evaluated the safety and efficacy of AdFIrst compared to the standard of care (cryoprecipitate or fresh frozen plasma) in patients with AFD.

The trial met its primary endpoint by demonstrating non-inferiority to the standard of caAdFIrsteducing intraoperative blood loss during a major spinal or abdominal surgery. Mean blood loss volume was 1,444mL and 1,735mL in the treatment and standard of care groups, respectively.

AdFIrst (adjusted fibrinogen replacement strategy) was developed as a fibrinogen alternative to standard fibrinogen therapies for AFD such as cryoprecipitate, a plasma extract, and fresh frozen plasma. Grifols added BT524 as part of its portfolio following the acquisition of Biotest in 2022.

AdFIrsto:FDA grants fast track status to Edgewise’s Duchenne treatmentfibrinogen Grifols Grifols BT524 Biotest

AFD can bFDAaused by a variety of reasonsEdgewiseng trauma, medication, malignancy, and underlying clotting disorders like disseminated intravascular coagulopathy (DIC). AFD results in a low fibrinogen level, which plays an important role in blood clotting.

Grifols has experienced turmoil in recent months. Last month, Gotham City Research released a report accusing the company of artificially manipulating its debt and earnings through transactions with a company related to the Grifols family, who own controlling interest in Grifols. The allegation plunged the company’s stock by more than 40%. The stock has not recovered in value to what it was worth before the allegations were made.

Following the news, Grifols has changed its managemetrauma“separate its malignancy from ownership”.clotting disorderspment disseminated intravascular coagulopathy (DIC)u stepping down from thfibrinogenas chief corporate officer and chief operating officer, respectively.

Grifols Grifolsherapies Grifols is currently developing include Albutein (albumen therapy) and emphysema treatment. In July 2023, the company completed the enrolment of patients in its Phase III PRECIOSA trial (NCT03451292) of long-Grifolsbutein (albumin-human injection) therapy Grifols Grifolsease the survival time in patients with decompensated cirrhosis. Topline data from the study is expected in Q4 of this year.

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