GrifolsGrifols gears up for FDA approval of fibrinogen replacement therapy

临床3期临床结果高管变更快速通道
Grifols gears up for FDA approval of fibrinogen replacement therapy
Preview
来源: Pharmaceutical Technology
GrifolsGrifols 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.
Spanish pharmaceutical company GrifolsGrifols 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 regulatory approval for the therapy in both Europe and the US in Q4 of this year.
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 care in reducing 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. GrifolsGrifols added BT524 as part of its portfolio following the acquisition of Biotest in 2022.
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Grifols gears up for FDA approval of fibrinogen replacement therapy
Preview
来源: Pharmaceutical Technology
AFD can be caused by a variety of reasons including 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.
GrifolsGrifols 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 GrifolsGrifols. 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 management to “separate its management from ownership”. The latest development involved Raimon Grifols and Víctor Grifols Deu stepping down from their roles as chief corporate officer and chief operating officer, respectively.
Other therapies GrifolsGrifols 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-term Albutein (albumin-human injection) therapy to increase the survival time in patients with decompensated cirrhosis. Topline data from the study is expected in Q4 of this year.
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