FDA Approves Ruconest to Treat Hereditary Angioedema Attacks

The Food and Drug Administration July 17 said that it approved Ruconest, which it called the first recombinant C1-esterase inhibitor product for treating acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

The agency said Ruconest is manufactured by Pharming Group NV, a company based in the Netherlands, and will be distributed in the U.S. by Santarus Inc., a wholly owned subsidiary of Salix Pharmaceuticals Inc., of Raleigh, N.C. The agency approved the drug July 16, according to its statement.

The FDA said that HAE is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor. ...