New Treatment Option for Hemophilia Approved

The US Food and Drug Administration recently approved the Biologics License Application for Rebinyn (Coagulation Factor IX [Recombinant], GlyoPEGylated) for the treatment of hemophilia B in adult and pediatric patients. The drug replaces the clotting Factor IX missing from patients with hemophilia B, and is indicated for on-demand treatment and control of bleeding episodes and the perioperative management of bleeding for patients with hemophilia B.

Rebinyn is administered as an infusion and should be initiated by a health care provider. Patients can receive Rebinyn either at a health care facility or at home after initiation. Those who chose to perform the infusion at home should be trained on the appropriate administration methods.
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The efficacy and safety of Rebinyn was determined based on 4 clinical trials that included 115 patients.

Common adverse effects associated with Rebinyn include swelling, pain, rash or redness at the infusion site, itching, and allergic reactions. In addition, Rebinyn increases the risk of blood clots.

Patients can develop inhibitors against Rebinyn, which could reduce the effectiveness of the drug, and may require periodic blood tests to determine if they have developed inhibitors.

—Melissa Weiss

Reference:

FDA approves new Novo Nordisk treatment for patients with hemophilia [press release]. Plainsboro, NJ: Novo Nordisk; May 31, 3017. http://press.novonordisk-us.com/2017-05-31-FDA-Approves-New-Novo-Nordisk-Treatment-for-Patients-with-Hemophilia. Accessed June 1, 2017.