Salix, Pharming Report FDA Approval Of RUCONEST For Acute Angioedema Attacks

(RTTNews) - Salix Pharmaceuticals, Ltd. (SLXP) and Pharming Group NV (PHGUF.PK, PHGUF.OB) announced that the Food and Drug Administration or FDA has approved RUCONEST 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema or HAE. Owing to limited number of patients with laryngeal attacks, effectiveness was not established in HAE patients with laryngeal attacks.

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.

Pharming's Chief Executive said: "The approval of RUCONEST® in the US is a very significant milestone for Pharming. For many years we have strived to make RUCONEST® - the first recombinant replacement therapy for C1Inhibitor deficiency - available to the HAE patient community in the US, because we were aware of the great value and benefit this product adds to patients' lives. Today we are proud to have achieved this goal in the US."

RUCONEST is manufactured by Pharming Group in the Netherlands. Salix has licensed exclusive rights from Pharming to commercialize RUCONEST in North America and market RUCONEST to treat acute HAE attack symptoms. Currently, Salix plans on making RUCONEST accessible to patients later in 2014.