Cuvitru Approved for Primary Immunodeficiency

The FDA has just approved Shire's Cuvitru for primary immunodeficiency in patients 2 years and older.

The FDA has just approved Shire’s immune globulin subcutaneous (human), 20% solution (Cuvitru) for primary immunodeficiency (PI) in patients 2 years and older.

PI is a group of more than 300 genetic disorders where part of the body’s immune system is missing or functions improperly. It affects as many as 6 million individuals worldwide.

Cuvitru is the only 20% subcutaneous immunolglobulin (IG) 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 IG treatments. Regardless of infusion rate or volume per site, the drug was generally associated with a low incidence of local adverse and systemic reactions in a phase 2/3 study among North American patients that was recently published in the Journal of Clinical Immunology.

“The availability of Cuvitru as a high-concentration, subcutaneous IG provides PI patients with the dosing flexibility that allows them to customize their therapy to best fit their individual needs,” stated Richard L. Wasserman, MD, PhD, Medical Director of Pediatric Allergy and Immunology at Medical City Children's Hospital, in a press release about the product’s approval.

Shire expects to launch Cuvitru in the United States in the coming weeks. The treatment was approved in 17 European countries in June 2016, and Shire expects to initiate additional global regulatory submissions for it in late 2016 and 2017.

Like other IG products, Cuvitru carries a Boxed Warning for thrombosis. For those at risk of thrombosis, health care professionals should administer the drug at the minimum dose and infusion rate practicable, and then monitor for signs and symptoms of thrombosis and assess blood viscosity in those at risk of hyperviscosity.

Other warnings and precautions include renal dysfunction/failure, aseptic meningitis syndrome, transfusion-related acute lung injury, transmittable infectious agents, and interference with laboratory tests. The most common adverse reactions observed in clinical trials were headache, nausea, fatigue, diarrhea, and vomiting.