Pharming of the Netherlands and Salix Pharmaceuticals are celebrating after getting the green light from regulators in the USA for its hereditary angioedema treatment Ruconest.

Specifically, the Food and Drug Administration has approved Ruconest, the first recombinant C1-esterase Inhibitor for the treatment of acute attacks in patients with HAE. The rare genetic condition, which affects 6,000-10,000 people in the USA, results in sufferers developing rapid swelling of the hands, feet, limbs, face, intestinal tract or airway; the latter is potentially fatal without immediate treatment.

Ruconest, which was approved in Europe in 2010, was developed through Pharming's proprietary technology in the milk of transgenic rabbits. The approval is based on a trial which showed the median time to beginning of symptom relief was 90 minutes for Ruconest patients (n=44) versus 152 minutes for those on placebo (n=31).

Sijmen de Vries, Pharming chief executive, said the approval “is a very significant milestone” for the firm as “for many years we have strived to make Ruconest available to the HAE patient community in the US, because we were aware of the great value and benefit” of the product.

Ruconest will be distributed in the USA by Salix’ Santarus subsidiary later this year.