Shire's immunology portfolio has been given a boost with US approval for Cuvitru for the treatment of primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body's immune system is missing or failing.
Cuvitru is a new subcutaneous immunoglobulin treatment that does not contain the amino acid proline. Shire says it offers patients a new therapeutic option to meet their needs, "particularly related to the number of infusion sites and infusion time".
The product is the only 20 percent subcutaneous immunoglobulin treatment option without proline and with the ability to infuse up to 60 mL per site and 60 mL per hour, per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments, the firm said.
"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," noted Richard Wasserman, medical director of Pediatric Allergy and Immunology at Medical City Children's Hospital.
Shire is planning to roll out the drug - which was approved in Europe back in June - in the US this autumn.