Grifols Achieves Positive Topline Results from Phase 3b Study of its Fibrin Sealant to Treat Surgical Bleeding in Pediatric Patients

All primary and secondary endpoints met, with Grifols Fibrin Sealant (FS) showing a positive safety and tolerability profile

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Summation

  • 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.

Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global leader in plasma medicines with more than 110 years contributing to improve the health and well-being of people, today announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding obtained positive topline results from a phase 3b clinical trial 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 innovative 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]