FDA/CDC

FDA approves Rebinyn for hemophilia B treatment


 

The Food and Drug Administration has approved Rebinyn (nonacog beta pegol, N9-GP) for the treatment of hemophilia B, according to a statement from Novo Nordisk.

Caused by deficient blood clotting factor IX activity, hemophilia B affects about 5,000 people in the United States. The disease is chronic and inherited and causes prolonged and spontaneous bleeding, particularly into muscles, joints, or internal organs. Rebinyn is intended to control and treat bleeding episodes, as well as provide perioperative management of bleeding.

The FDA has approved Rebinyn for both adult and pediatric patients, based on results from clinical trials comprising 115 hemophilia B patients. The most common side effects are swelling, pain, rash, or redness at the location of infusion and itching.

Find the full statement about Rebinyn’s approval on the Novo Nordisk website.

Recommended Reading

Sickle cell trait artificially lowers HbA1c
MDedge Family Medicine
Study: No link between vaccines, inhibitor development
MDedge Family Medicine
ITI protects against bleeding in hemophilia A with factor VIII inhibitors
MDedge Family Medicine
Boys with severe hemophilia have good physical function
MDedge Family Medicine
Study highlights importance of genotyping in von Willebrand disease
MDedge Family Medicine
New diagnostic tool identifies severe ADAMTS13 deficiency
MDedge Family Medicine
DTC genetic health risk tests: Beware
MDedge Family Medicine
Blood donor age, sex do not affect recipient survival
MDedge Family Medicine
Consider switch to clopidogrel for DAPT early post ACS
MDedge Family Medicine
FDA advisory committee supports L-glutamine for SCD
MDedge Family Medicine