FDA OKs Immune Globulin Cuvitru for Primary Immunodeficiency

Megan Brooks

Disclosures

September 15, 2016

The US Food and Drug Administration (FDA) has approved immune globulin subcutaneous (SC) (human) 20% solution (Cuvitru, Shire) for primary immunodeficiency in adults and children aged 2 years and older, the company has announced.

Patients with primary immunodeficiency disease typically need life-long intravenous or SC immunoglobulin replacement therapy to prevent recurrent infections.

Cuvitru is the only 20% subcutaneous immunoglobulin treatment option without proline and with the ability to infuse up to 60 mL (12 g) per site and 60 mL per hour, per site, as tolerated, resulting in fewer infusion sites and shorter infusion durations compared with other conventional subcutaneous immunoglobulin treatments, Shire notes in a news release.

"The availability of Cuvitru as a high-concentration, subcutaneous [immunoglobulin] provides primary immunodeficiency patients with the dosing flexibility that allows them to customize their therapy to best fit their individual needs," Richard L. Wasserman, MD, PhD, medical director, Pediatric Allergy and Immunology at Medical City Children's Hospital, Dallas, Texas, said in the release.

The approval follows the August 31 publication in the Journal of Clinical Immunology of a phase 2/3study of Cuvitru in North American patients with primary immunodeficiency. A total of 74 patients (aged 3 to 83 years) received 4327 SC infusions over a median of 380.5 days.

In the study, Cuvitru was "effective and safe, enabling higher infusion rates and volumes per site compared to conventional SC treatments, resulting in fewer infusion sites and shorter infusion durations," the investigators conclude in their article.

Regardless of infusion rate or volume per site, Cuvitru was generally associated with a low incidence of local adverse and systemic reactions (0.022 per infusion and 0.042 per infusion, respectively).

"In the clinical study, primary immunodeficiency patients tolerated Cuvitru favorably despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past," Dr Wasserman commented in the release.

Marcia Boyle, president and founder of the Immune Deficiency Foundation, said, "As the national patient organization dedicated to people with primary immunodeficiency, the Immune Deficiency Foundation is delighted to see new treatment options that can address patients' clinical priorities as well as their personal preferences, particularly in terms of dosing and administration."

Shire said Cuvitru should be available in the United States "in the coming weeks." Cuvitru is already approved in 17 European countries.

Primary immunodeficiencies are a group of more than 300 disorders in which part of the body's immune system is missing or does not function properly. It is estimated that as many as 6 million children and adults may be affected by primary immunodeficiencies worldwide.

Cuvitru is for SC infusion only. The label contains a boxed warning stating that thrombosis may occur with immunoglobulin products, including Cuvitru. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

For patients at risk for thrombosis, Cuvitru should be administered at the minimum dose and infusion rate practicable and patients should be adequately hydrated before administration. Patients should be monitored for signs and symptoms of thrombosis and blood viscosity assessed in patients at risk for hyperviscosity.

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