Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP)
Angioedema means swelling beneath the surface of the skin. Hereditary angioedema (NYSE:HAE) is an inherited disease that causes repeated episodes of swelling.
In HAE, the swelling and associated inflammation can be confined to the face, hands, feet, arms and legs. However, dangerous swelling in the airways-trachea (windpipe) or larynx (voice box)-or intestinal tract can also occur. When it occurs in the abdomen, this swelling can be accompanied by bouts of nausea, vomiting and severe pain. Swelling in the face or extremities can be painful, disfiguring, and disabling.
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.
SLXP and Pharming Group NV reported that the Food and Drug Administration has approved RUCONEST(NYSE:R) (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.
RUCONEST(R) (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with HAE.
HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. RUCONEST, the first and only plasma-free, recombinant C1-INH approval from the FDA, contains C1 esterase inhibitor at 50 IU/kg.
RUCONEST has been granted Orphan Drug designation by the FDA for the treatment of acute angioedema attacks in patients patients with HAE. With RUCONEST now approved by the FDA, SLXP believes this designation should provide seven years of marketing exclusivity in the United States.
RUCONEST is manufactured by Pharming Group NV in the Netherlands. SLXP has licensed exclusive rights from Pharming to commercialize RUCONEST in North America and market RUCONEST for the treatment of acute HAE attack symptoms.
SLXP develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases. SLXP's strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and commercialize them through the Company's 500-member specialty sales force.
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.