Written by Jack Goldman, CNN
Covidien’s new intravenous immunoglobulin treatment is approved by the US Food and Drug Administration (FDA) in all US centers and support personnel.
(CNN) – With children born with immune deficiencies frequently facing the threat of cancer and death, a blood-based treatment that targets the abnormal immune responses in these children to potentially avoid these devastating outcomes is now available.
Covidien’s new intravenous immunoglobulin treatment is approved by the US Food and Drug Administration (FDA) in all US centers and support personnel. The treatment was submitted under a special access program.
Patients with severely compromised immune systems are at an increased risk of getting viral infections, such as influenza or Lyme disease, which can then lead to heart failure or a rare condition known as Inflammatory Bowel Disease (IBD).
Covidien’s amikacin-based IGA product is a low-dose intravenous infusion that targets IgG. IgG is a component of the immune system that looks for foreign materials. As it processes a foreign material, IgG can trigger an immune response that can lead to inflammation and/or possibly lead to fatal reactions.
“We are excited to provide this new treatment option for this group of patients,” said Pablo Guzman, senior vice president, Global Infusion business, Covidien. “In addition to providing physicians and patients the ability to more safely and effectively treat patients with IBD, amikacin-IGA supports our commitment to delivering comprehensive medication management services to ensure patients receive the most appropriate drugs in the shortest possible time.”
The FDA said the treatment offers “slimming relief” to patients with highly compromised immune systems, and also reduces the risk of secondary bacterial infections.
The approval applies to a combination of combination forms of amikacin and methotrexate to treat IgG lytic myocarditis (a rare blood disorder in which abnormal Mycobacterium euniformis spirochete (M. euniformis) activity is triggered by stressors in the blood), IgG myocarditis (in which white blood cells cause excessive inflammation in the heart), non-provisional antibody conversion hypoplasia (a condition where patients fail to secrete antibodies) and IgG deficiency IIb-IV (in which a patient’s blood-borne IgG reacts to infection or respiratory illness in unusual ways and changes over time.)
An estimated 60,000 to 80,000 people in the US have IgG deficiency, with high rates in people with respiratory infections or allergic reaction, including asthma, a type of eczema, and irritable bowel syndrome.
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