Salix and Pharming Announce FDA Approval of Ruconest

Salix Pharmaceuticals and Pharming Group NV has won FDA approval of Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Because of the limited number of patients with laryngeal attacks, effectiveness was not established in HAE patients with laryngeal attacks.

“We are pleased that Ruconest provides the HAE community with another FDA-approved option for treating painful and debilitating HAE attacks,” said Anthony Castaldo, President of the Hereditary Angioedema Association (US HAEA), a non-profit patient services and research organization with a membership of over 5000 HAE patients in the US.

Ruconest is a recombinant C1 esterase inhibitor that can be administered by the patient after receiving training by a healthcare provider. HAE attacks stem from a deficiency of the C1 inhibitor protein in the blood. HAE is a rare inherited genetic condition that is often not properly diagnosed until later in a patient’s life as the symptoms of an attack can mirror someone experiencing an allergic reaction. Severe, painful swelling can occur at any time, which means most people suffering from HAE deal with the constant fear of when their next attack might surface and how that might impair their lives and those around them.

“Results in the pivotal clinical trial demonstrate Ruconest is a safe and effective option for the treatment of acute hereditary angioedema attacks,” said Dr Marc Riedl of the US HAEA Angioedema Center at the University of California – San Diego and primary investigator of the Phase III study. “At the US HAEA Angioedema Center, we strive to better the lives of those suffering from hereditary angioedema and part of that is ensuring patients have access to advanced treatments that have been proven to work in clinical trials. Ruconest is an important addition to those treatment options.”