FDA approves cutaquig for children with primary humoral immunodeficiency

The FDA approved immune globulin subcutaneous (human)-hipp, 16.5% solution, or cutaquig, for the treatment of children aged at least 2 years with primary humoral immunodeficiency, according to a press release.

Cutaquig (Octapharma) — which was previously approved for adults with primary humoral immunodeficiency — can be administered at a lower dose more frequently or at a larger dose less frequently depending on patient and provider preference. Patients who want to avoid frequent injections can receive the therapy every other week, whereas patients who respond better to frequent therapy can receive daily dosing.

“The FDA approval provides physicians and families with more treatment options for patients with primary immune disorders, which weaken the immune system and can allow infections and other health issues to occur more easily,” Roger H. Kobayashi, MD, clinical professor at UCLA School of Medicine and national consultant for the Immune Deficiency Foundation, said in the release. “The FDA approval also provides more flexible options by permitting more frequent or less frequent infusions, which can be advantageous based on a patient’s pharmacokinetic and clinical response.”

This approval is based, in part, on data from two clinical trials that included 37 adults and 38 children aged 2 to 17 years with primary humoral immunodeficiency. The patients received weekly cutaquig infusions during a 12-week wash-in/wash-out period, followed by a 12-month efficacy period.

Preventing serious bacterial infections — including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess — served as the main research objectives. Researchers reported no serious bacterial infections during the trials.

“Cutaquig provides enhanced convenience for a wider group of patients who want to customize therapy with their prescriber to best match patient lifestyle needs,” Flemming Nielsen, U.S. president of Octapharma, said in the release. “Octapharma is committed to providing people with immune disorders the lifesaving therapies they need. 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.”