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FDA approves Rebinyn for hemophilia B
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The FDA approved the biologics license application for coagulation Factor IX (recombinant), glycoPEGylated for the treatment of adults and children with hemophilia B, according to the drug’s manufacturer.
Coagulation Factor IX (recombinant), glycoPEGylated (Rebinyn, Novo Nordisk) is a recombinant DNA–derived coagulation Factor IX concentrate to treat and control bleeding episodes, as well as for the perioperative management of bleeding.
The application included safety and efficacy results from four paradigm clinical trials designed to evaluate Rebinyn in 115 patients with hemophilia B.
“We would like to thank the patients who participated in the clinical studies that led to this decision. Thanks to their commitment, we are able to continue to provide new medicines for people with hemophilia,” Bill Breitenbach, vice president of biopharmaceuticals portfolio at Novo Nordisk, said in a company-issued release. “We are committed to the hemophilia community and will continue on our path to bring this new extended half-life treatment to patients who need it.”
The approval follows the Blood Products Advisory Committee meeting held on April 4.
The company is expected to launch Rebinyn next year, the release said.