The US Food and Drug Administration (FDA) has granted approval for Shire’s Cuvitru treatment in adult and paediatric patients aged two years and older.
Cuvitru is used to treat patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body’s immune system is missing or does not function properly.
Cuvitru is the only 20% subcutaneous immunoglobulin (IG) option without proline and has the ability to infuse up to 60ml a site and 60ml an hour.
It is generally associated with a low incidence of local adverse and systemic reactions in the North American clinical study.
Medical City Children Hospital pediatric allergy and immunology medical director Richard Wasserman said: “In the clinical study, primary immunodeficiency patients tolerated Cuvitru favourably, despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past.
“The availability of Cuvitru as a high-concentration, subcutaneous IG provides primary immunodeficiency patients with the dosing flexibility that allows them to customise their therapy to best fit their individual needs."
Approved in 17 European countries in June, Cuvitru is expected to be launched in the US soon.
The company also expects to initiate additional global regulatory submissions for the drug this year and next year.
Shire US commercial head Perry Sternberg said: “As Cuvitru is now approved in the US following European approval earlier this year, Shire’s broad IG treatment portfolio offers a wide range of options to help physicians tailor treatment regimens to meet the priorities of their patients managing these life-long disorders.”