The Food and Drug Administration (FDA) has expanded the approval of cutaquig® (immune globulin, subcutaneous [human]-hipp 16.5% solution) to include patients 2 years of age and older with primary humoral immunodeficiency. Previously, the treatment was only approved for adults.

The approval was based on data from a pivotal study that evaluated cutaquig in 75 patients with primary humoral immunodeficiency, including 37 adults and 38 children aged 2 to 17 years. Patients received weekly subcutaneous infusions of cutaquig during a 12-week wash-in/wash-out period followed by a 12-month efficacy period.

The primary endpoint was to assess the efficacy of cutaquig in preventing serious bacterial infections, defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess. No serious bacterial infections were reported at any time during the study.

Cutaquig is a ready-to-use immune globulin solution for subcutaneous infusion. The product is available in 1g, 1.65g, 2g, 3.3g, 4g, or 8g single-use vials.

“Cutaquig provides enhanced convenience for a wider group of patients who want to customize therapy with their prescriber to best match patient lifestyle needs,” said Octapharma USA President Flemming Nielsen. “Both the addition of the pediatric indication and the flexible dosing illustrate our commitment to ensure patients have access to lifesaving products that offer a variety of choices for therapy delivery.”

References

  1. FDA approves Octapharma’s cutaquig® 16.5% for pediatric PI patients, providing flexible treatment options. News release. Octapharma USA. Accessed December 7, 2021. https://www.businesswire.com/news/home/20211207005329/en/FDA-Approves-Octapharma%E2%80%99s-cutaquig%C2%AE-16.5-for-Pediatric-PI-Patients-Providing-Flexible-Treatment-Options
  2. Cutaquig. Package insert. Octapharma USA; 2021. Accessed December 7, 2021. https://www.cutaquigus.com/wp-content/uploads/2021/11/cutaquig-full-prescribing-information.pdf.