FDA Approves Cutaquig for Treatment of Children With Primary Humoral Immunodeficiency
Families and providers can use a flexible infusion schedule to meet patient needs, Octapharma says.
The FDA has 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 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 the UCLA School of Medicine and National Consultant, Immune Deficiency Foundation. “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.”Patients and providers can administer the solution at a lower dose more frequently or a larger dose less frequently if desired. Patients who prefer less frequent injections may have the option of receiving therapy every other week. Physicians can prescribe daily dosing if patients respond better to more frequent therapy.
“Cutaguig 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, president of Octapharma USA, said in a statement.
“Octapharma is committed to providing people with immune disorders the life-saving 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,” Nielsen saidThe 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.
Individuals who are at risk for thrombosis should administer the solution at the minimum dose and infusion rate and ensure adequate hydration beforehand.
Patients should also monitor for signs and symptoms of thrombosis and assess blood viscosity when at risk of hyperviscosity.
Globally, millions of people suffer with primary immunodeficiencies, a group of more than 400 different diseases, according to the statement. Approximately 1 in every 10,000 individuals have PI, but the diseases are even more prevalent in children. Between 70% and 90% of individuals living with a PI remain undiagnosed.
FDA approves Octapharma’s cutaguig® 16.5% for pediatric PI patients, providing flexible treatment options. News release. December 7, 2021. Accessed December 7, 2021. Email.