Pharming Group and Salix Pharmaceuticals have introduced Ruconest (C1 esterase inhibitor [recombinant]) 50IU/kg in the US, a treatment developed to treat acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).
Ruconest can be administered by the patient after receiving training by a healthcare provider.
According to Pharming, efficacy of Ruconest in clinical studies was not established in HAE patients with laryngeal attacks.
Salix Pharmaceuticals CEO Carolyn Logan said: “We’re excited to offer the only recombinant C1 esterase inhibitor therapy for HAE in the US.
“Ruconest treats the root cause of HAE attacks, which has been shown to raise C1 inhibitor levels to within the normal range.
Ruconest can be self-administered by appropriately trained patients and is effective at stopping most HAE attacks in one dose.”
The drug has been introduced following US Food and Drug Administration (FDA) approval in July.
Pharming produces Ruconest in the Netherlands, while Salix received exclusive rights from Pharming to commercialise the drug in North America, and market it for the treatment of acute HAE attack symptoms.
Pharming CEO Sijmen de Vries said: “Ruconest helped patients in other countries around the world and we look forward to seeing the difference it will make in the lives of HAE patients in the US.”
HAE is a rare genetic condition, which affects one in 10,000 and one in 50,000 people, and it results in episodes of swelling in different parts of the body, including the hands, feet, abdomen and face.
Image: Swollen right hand in a female patient during a hereditary angioedema attack. Photo: courtesy of LucyHAE.
