Cutaquig was recently approved for the treatment of pediatric patients aged 2 years and older with primary humoral immunodeficiency.
On December, 8, 2021, the FDA approved Octapharma’s cutaquig, an immune globulin, subcutaneous (human)-hipp 16.5% solution cutaquigfor the treatment of pediatric patients aged 2 years and older with primary humoral immunodeficiency (PI). The agency had previously approved the solution for adults with PI.
The FDA’s approval of cutaquig was based on the results of 2 clinical trials that included 75 individuals with PI: 37 were adults, and 38 were pediatric patients aged 2 through 17 years. The individuals received weekly infusions with cutaquig during a 12-week wash-in/wash-out period, followed by a 12-month efficacy period.
The trials were meant to assess the efficacy of cutaquig in preventing serious bacterial infections, defined as bacterium/sepsis, bacterial meningitis, bacterial pneumonia, osteomyelitis/septic arthritis, and visceral abscess. No bacterial infections were reported. Thrombosis may occur with immune globulin products, including cutaquig, and risk factors may include advanced age, cardiovascular risks, estrogen use, history of arterial or venous thrombosis, hypercoagulable conditions, hyperviscosity, prolonged immobilization, and indwelling vascular catheters.