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Launch of Ruconest® in the U.S. for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE)

Pharming Group NV and Salix Pharmaceuticals, Ltd. has announced the launch of RUCONEST® (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg in the United States for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks. Today’s announcement follows the July approval of the drug by the Food and Drug Administration.

“We’re excited to offer the only recombinant C1 esterase inhibitor therapy for HAE in the United States,” said Carolyn J. Logan, President and Chief Executive Officer of Salix. “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.”

RUCONEST, a recombinant C1 esterase inhibitor, can be administered by the patient after receiving training by a healthcare provider. RUCONEST is over 98 percent pure, and because it is not made from human plasma, it does not carry any known risk of passing on viruses that can be found in human blood.

HAE is a rare genetic condition that affects between 1 in 10,000 to 1 in 50,000 people. It causes episodes of swelling in various parts of the body, including the hands, feet, abdomen and face. Patients with abdominal swelling often experience severe pain, nausea and vomiting. HAE attacks stem from a deficiency of the C1 inhibitor protein in the blood. The disease is often misdiagnosed, 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.

“HAE is an especially challenging disease for patients to manage,” said Anthony Castaldo, President of the Hereditary Angioedema Association (US HAEA), a non-profit patient services and research organization with a membership of over 5,000 HAE patients in the United States. “If left untreated, patients can experience attacks that are incredibly painful and, because of its unpredictability, HAE interferes with daily life. We’re pleased HAE patients now have another treatment option available to them.”

RUCONEST is available by prescription across the United States through RUCONEST SOLUTIONS and comes with comprehensive patient support services. For more information, including an opportunity for a free trial of RUCONEST, visit Ruconest.com or call RUCONEST® SOLUTIONS at (855) 613-4HAE.

RUCONEST is manufactured by Pharming Group NV in the Netherlands. Salix has licensed exclusive rights from Pharming to commercialize RUCONEST® in North America and market RUCONEST for the treatment of acute HAE attack symptoms.

“RUCONEST’s availability in the United States marks a significant milestone for Pharming,” said Sijmen de Vries, CEO of Pharming. “RUCONEST has 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 U.S.”

Indication:
RUCONEST® is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks.

Important Safety Information for RUCONEST

RUCONEST® (C1 esterase inhibitor [recombinant]) is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products, and patients with a history of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis.

Severe hypersensitivity reactions may occur. The signs and symptoms of hypersensitivity reactions may include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis during or after injection of RUCONEST. Should symptoms occur, discontinue RUCONEST and administer appropriate treatment. Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered.

Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with risk factors. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Monitor patients with known risk factors for TE events during and after RUCONEST administration.

RUCONEST has not been studied in pregnant women; therefore, it should only be used during pregnancy if clearly needed.

The most common adverse reactions (incidence ?2%) were headache, nausea, and diarrhea. The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.

Source

Source: Pharming Group NV and Salix Pharmaceuticals Ltd