预约演示

Grifols Grifols readies US, EU approval push for blood clot treatment after phase 3 success

2024-02-14

上市批准临床结果临床3期临床2期

BT524 can be administered to “patients on the operating table immediately," Grifols explained.

BT524ls is readying an approval run at U.S. and European regulators on the bGrifolsa phase 3 win for the Spanish plasma medicine producer's concentrated form of a blood clotting factor.

Grifols Grifolsduct, dubbed BT524, is a concentrated form of fibrinogen, a glycoprotein that is essential for blood clot formation and stops excessive bleeding resulting from injuries or surgery. Grifols was testing BT524 in a late-stage study of patients with acquired fibrinogen deficiency (AFD), which it described as an “underserved growth market.”

The Barcelona, SpainBT524d company announced this morfibrinogenthe product had met the study’s primary endpoint, demonstrating its noninferiority to standard of care when it came to reduciGrifols Grifolsd loss in patBT524 with AFD who underwent spinal or abdomiacquired fibrinogen deficiency (AFD) an excellent safety profile.”

Specifically, mean blood loss was 1,444 mL among the BT524 cohort compared with 1,735 mL among patients who received standard of care. It meant patients receiving Grifols’ product lost an average of 291 mL less blood.

AFD usually occurs during surgery when a patient’s boBT524ntains insufficient fibrinogen to arrest bleeding. It is typically treated with a plasma extract called cGrifolsipitate or fresh frozen plasma, which both contain fibrinogen.

However, both of these treatment options contain various other unneeded proteifibrinogenments, meaning that large volumes are required to ensure the patient receives sufficient fibrinogen, Grifols explained in the releasefibrinogeno need to be thawed before use, which is not only time-consuming but can put patients’ lives at risk, the company added.

In contrast, BT524 can be administered to “patients on the operating table immediately,” who will only receive the fibrinogen necessary to prevent hemorrhaging, Grifols explained.Grifols

The company’sBT524 is to kick off the approval process in both Europe and the U.S. in the fourth quarter of the yeafibrinogenessful, it would mark the first fibrGrifolsconcentrate approved for AFD in the U.S., Grifols noted.

“The positive results for fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma,fibrinogen concentraternal and external investments, Grifols Grifolsludes both shorter- and longer-term development cycles,” Grifols’ chief operating officer, Victor Grifols Deu, said in the release.

While Grifols has its eye on the first fibrinogen concentrate approval for AFD in the U.S., its competitors have had more luck getting their own versions to market for congenital fibrinogen deficiency. CSL Behring got RiaSTAP approved in that indication as far back as 2009, while Switzerland’s Octapharma followed suit with Fibryga in 2017. Since then, Fibryga has also received approval to treat AFD across Europe off the back of a phase 2 study.

MeanwhGrifols Grifolsifols is in the midst of an ongoing legal battle with Gotham City Research after the New York hedge fund accused the company of wrongful accounting practiccongenital fibrinogen deficiency CSL Behring RiaSTAP Octapharma Fibryga Fibryga

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构