BRIEF—New product labelling for Octapharma products

The US Food and Drug Administration (FDA) has approved two supplements to Biological License Applications from human protein manufacturer Octapharma, strengthening the family-owned company’s pediatric critical care product portfolio.

The Octaplas labeling now provides the results of two post-marketing studies evaluating the product’s efficacy, safety and tolerability for newborns through age 20.

Octaplas, an alternative to fresh frozen plasma, was evaluated in 91 pediatric patients up to age 20. There were no hyperfibrinolytic or treatment-related thromboembolic events reported by investigators. Results of these studies support the use of Octaplas in critically ill pediatric patients.

For Fibryga (human fibrinogen concentrate), the FDA approved Octapharma’s request to expand the indication for on-demand treatment of acute bleeding episodes to pediatric patients less than 12 years old with congenital fibrinogen deficiency, also known as Factor 1 deficiency.