Grifols Shares Positive Results From Fibrin Sealant Study

Grifols is touting positive topline results from a phase 3b clinical trial of its plasma-protein based fibrin sealant (FS) in pediatric patients.
 
Having met all primary and secondary endpoints, the study is expected to facilitate regulatory approval to expand the use of the FS-based biosurgery treatment, currently indicated for adults, to children and adolescents as well. 
 
Known commercially as VISTASEAL in the United States and VERASEAL in Europe, Grifols FS is marketed and distributed by Ethicon, a Johnson & Johnson MedTech company, as part of a strategic collaboration between the two companies announced in 2019.
 
Grifols FS combines two plasma proteins, fibrinogen and thrombin, and is applied with Ethicon’s airless spray technology to rapidly form clots. Since being introduced a few years ago, the FS product has launched in 20 countries.
 
Researchers investigating the application of Grifols FS to pediatric patients, defined as not having reached 18 years of age, conducted a prospective, randomized, active-controlled, single-blind, parallel group clinical trial. Designed to evaluate the safety and efficacy of the FS as an adjunct to hemostasis during surgery in pediatric subjects, the international study included a total of 178 patients enrolled and treated across 18 recruitment centers.
 
In both treatment arms, Grifols FS had a 95% efficacy rate, achieving hemostasis within four minutes of application. In addition, the solution demonstrated a good safety and tolerability profile, as the distribution of adverse events was comparable between arms.
 
The trial fulfills legal and regulatory obligations as well as supports regulatory licenses from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
 
“Our work in developing biosurgery solutions is a reflection of Grifols’ ability to apply its ever-deeper knowledge of plasma science and other biopharmaceuticals to treat patient needs across multiple therapeutic areas,” said Cesar Cerezo, Grifols senior vice president of Drug Development.
 
It’s estimated that between roughly one-third and two-thirds of open surgeries experience disruptive bleeding,¹ while challenging and uncontrollable bleeding during surgery is associated with high mortality rates.^1,2
 
Grifols is a global healthcare company founded in Barcelona in 1909 that develops, produces, and provides healthcare services and solutions in more than 110 countries. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with more than 400 across North America, Europe, Africa and the Middle East and China. The company offers a portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services. It employs more than 27,000 workers in over 30 countries and regions.

References
¹ Corral M, Ferko N, Hollmann S, Broder MS, Chang E. Health and economic outcomes associated with uncontrolled surgical bleeding: a retrospective analysis of the Premier Perspectives Database. Clinicoecon Outcomes Res. 2015;7:409-421. doi:10.2147/CEOR.S86369
² Marietta M, Facchini L, Pedrazzi P, Busani S, Torelli G. Pathophysiology of bleeding in surgery. Transplant Proc. 2006;38(3):812-814. doi:10.1016/j.transproceed.2006.01.047