FDA grants approval to Ruconest

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced the approval of Ruconest, a recombinant C1-Esterase inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema.



Hereditary angioedema is caused by an insufficient amount of a plasma protein called C1-esterase inhibitor. The condition affects 6,000 to 10,000 people in the United States. People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract or airway, the agency said. The attacks may occur spontaenously or can be triggered by stress, surgey or infection. Swelling of the airway has the potenial to be fatal without immediate treatment.



“Hereditary angioedema is a rare and potentially life-threatening disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval provides an important treatment option for these patients.”



Ruconest received orphan-drug status from the FDA. The drug is manufactured by Pharming Group NV, Leiden, the Netherlands, and will be distributed in the United States by Santarus Inc., a subsidiary of Salix Pharmaceuticals.