Shire announced that the Food and Drug Administration (FDA) has approved Cuvitru (immune globulin subcutaneous [human]) 20% solution for the treatment of primary immunodeficiency in patients aged ≥2 years. 

Cuvitru is the only 20% subcutaneous immunoglobulin treatment without proline and with the ability to infuse up to 60mL/site and 60mL/hr as tolerated. This allows for fewer infusion sites and shorter infusion times compared to other standard subcutaneous immunoglobulin treatments.  

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The FDA approval was supported by a Phase 2/3 study among 74 North American patients. Most infusions (84.9%) were administered using ≤2 infusion sites; for 99.8% of infusions, there was no need to interrupt or stop administration or reduce the infusion rate. The study also found no related serious adverse event (AE) during treatment with Cuvitru; related non-serious adverse events occurred at a rate of 0.036 event per infusion. Related local adverse events occurred at a rate of 0.015 event per infusion. Overall, higher infusion rates or volumes were not associated with higher rates of adverse events. 

Cuvitru contains a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. 

Cuvitru will be available as a 20% strength protein solution for subcutaneous infusion. It will be supplied as single-use 5mL, 10mL, 20mL, and 40mL vials. Cuvitru is anticipated to launch in the coming weeks.

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