FDA approves Novo Nordisk's drug for rare bleeding disorder

PLAINSBORO, N.J. — Novo Nordisk on Monday announced that the Food and Drug Administration approved the company's NovoSeven RT (coagulation factor VIIa [recombinant]). The drug is the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann’s Thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets, the company said.

Glanzmann’s Thrombasthenia is a rare genetic bleeding disorder with limited treatment plans. It occurs when certain surface proteins on platelets are either missing or fail to work. This impacts the blood's ability to form an initial platelet "plug," which is the first step in building a strong blood clot, the company noted.

“Novo Nordisk is proud to build on our strong heritage of pioneering new therapies and indications for the bleeding disorders community by offering the only recombinant treatment for Glanzmann’s Thrombasthenia,” said Eddie Williams, senior vice president BioPharmaceuticals, Novo Nordisk. “We’re committed to keeping patients at the forefront of all we do, and this approval allows us to expand on this commitment.”