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news.Biogen and Swedish Orphan Biovitrum have started two paediatric trials of recombinant Factor VIII and Factor IX Fc fusion proteins (rFVIIIFc and rFIXFc).
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The open-label, multicenter studies will evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc and rFIXFc in previously-treated children with severe hemophilia A or B under the age of 12 years.
The first patient has been dosed in the rFIXFc paediatric study, and the rFVIIIFc paediatric study is now actively recruiting patients, according to the company.
Biogen hemophilia therapeutic area chief medical officer and global medical affairs senior vice president Glenn Pierce said, "The pediatric clinical trials are an important complement to the ongoing adult studies and further demonstrate our commitment to develop new treatments for the hemophilia community."
The Kids A-LONG study will evaluate rFVIIIFc in previously-treated paediatric patients with hemophilia A and the Kids B-LONG study will evaluate rFIXFc in previously-treated paediatric patients with hemophilia B.
The frequency of inhibitor development over an approximately 26-week treatment period and at least 50 exposure days to rFVIIIFc is the primary outcome measure and the number of annualised bleeding episodes and assessments of response to treatment over the same time period are the secondary outcome measures of the rFIXFc paediatric study.
The primary outcome measure of the rFVIIIFc pediatric study is the frequency of inhibitor development over an approximately 50-week treatment period and at least 50 exposure days to rFIXFc.
Secondary outcome measures include the number of annualised bleeding episodes and assessments of response to treatment over the same time period.